Trial Outcomes & Findings for BMAC & Allograft vs BMP-2 (NCT NCT02924571)

NCT ID: NCT02924571

Last Updated: 2025-07-08

Results Overview

The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 59 participants
• Primary outcome timeframe: Month 24 Post-Operation
• Results posted on: 2025-07-08

Participant Flow

Participant milestones

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Overall Study STARTED	20	20	19
Overall Study COMPLETED	19	19	19
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Overall Study Lost to Follow-up	1	1	0

Baseline Characteristics

BMAC & Allograft vs BMP-2

Baseline characteristics by cohort

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.	Total n=59 Participants Total of all reporting groups
Age, Continuous	58.1 years STANDARD_DEVIATION 12.9 • n=5 Participants	55.6 years STANDARD_DEVIATION 14.2 • n=7 Participants	55.9 years STANDARD_DEVIATION 13.6 • n=5 Participants	56.53 years STANDARD_DEVIATION 13.57 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	35 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	24 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	36 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	34 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	19 participants n=5 Participants	59 participants n=4 Participants

PRIMARY outcome

Timeframe: Month 12 Post-Operation

Fusion status assessed via CT scan by an independent radiologist.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Number of Participants With Successful Fusion Status at Month 12 Post-Procedure	17 Participants	16 Participants	16 Participants

PRIMARY outcome

Timeframe: Pre-Operation Visit (Day 0)

The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Oswestry Disability Index (ODI) Score at Pre-Op Visit	64.8 Percentage score Standard Deviation 4.2	66.1 Percentage score Standard Deviation 2.5	60.2 Percentage score Standard Deviation 2.6

PRIMARY outcome

Timeframe: Week 6 Post-Operation

The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
ODI Score at Week 6 Follow-Up	43.5 Percentage score Standard Deviation 3.8	40.2 Percentage score Standard Deviation 5.2	44.6 Percentage score Standard Deviation 5.1

PRIMARY outcome

Timeframe: Month 3 Post-Operation

The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
ODI Score at Month 3 Follow-Up	41.1 Percentage score Standard Deviation 4	40.6 Percentage score Standard Deviation 2.5	41.8 Percentage score Standard Deviation 2.9

PRIMARY outcome

Timeframe: Month 6 Post-Operation

The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
ODI Score at Month 6 Follow-Up	38.2 Percentage score Standard Deviation 3.4	40.3 Percentage score Standard Deviation 1.6	40.5 Percentage score Standard Deviation 2.1

PRIMARY outcome

Timeframe: Month 12 Post-Operation

The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
ODI Score at Month 12 Follow-Up	34.2 Percentage score Standard Deviation 2.2	36.5 Percentage score Standard Deviation 2.9	36.8 Percentage score Standard Deviation 2.4

PRIMARY outcome

Timeframe: Month 24 Post-Operation

The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
ODI Score at Month 24 Follow-Up	28.6 Percentage score Standard Deviation 2.4	30.5 Percentage score Standard Deviation 5.1	30.9 Percentage score Standard Deviation 3.6

PRIMARY outcome

Timeframe: Pre-Operation Visit (Day 0)

Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Numeric Rating Scale (NRS) - Back Pain Score at Pre-Op Visit	8.1 score on a scale Standard Deviation 0.8	7.6 score on a scale Standard Deviation 0.2	8.2 score on a scale Standard Deviation 0.3

PRIMARY outcome

Timeframe: Week 6 Post-Operation

Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
NRS - Back Pain Score at Week 6 Follow-Up	5.3 score on a scale Standard Deviation 1.6	5.6 score on a scale Standard Deviation 2.1	4.9 score on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: Month 3 Post-Operation

Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
NRS - Back Pain Score at Month 3 Follow-Up	4.8 score on a scale Standard Deviation 1.1	5.2 score on a scale Standard Deviation 1.3	4.7 score on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: Month 6 Post-Operation

Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
NRS - Back Pain Score at Month 6 Follow-Up	4.7 score on a scale Standard Deviation 1.3	5 score on a scale Standard Deviation 1.4	4.7 score on a scale Standard Deviation 1

PRIMARY outcome

Timeframe: Month 12 Post-Operation

Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
NRS - Back Pain Score at Month 12 Follow-Up	4.2 score on a scale Standard Deviation 1.4	4.6 score on a scale Standard Deviation 1.7	4.4 score on a scale Standard Deviation 1.2

PRIMARY outcome

Timeframe: Month 24 Post-Operation

Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
NRS - Back Pain Score at Month 24 Follow-Up	4 score on a scale Standard Deviation 1.1	4.1 score on a scale Standard Deviation 0.5	4.1 score on a scale Standard Deviation 0.9

PRIMARY outcome

Timeframe: Pre-Operation Visit (Day 0)

The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Short Form 12 (SF-12) - Physical Component Summary (PCS) Score at Pre-Op Visit	42.5 score on a scale Standard Deviation 0.9	47.6 score on a scale Standard Deviation 2.4	45.8 score on a scale Standard Deviation 1.8

PRIMARY outcome

Timeframe: Week 6 Post-Operation

The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
SF-12 - PCS Score at Week 6 Follow-Up	44.5 score on a scale Standard Deviation 1.3	48.4 score on a scale Standard Deviation 0.8	47.2 score on a scale Standard Deviation 1

PRIMARY outcome

Timeframe: Month 3 Post-Operation

The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
SF-12 - PCS Score at Month 3 Follow-Up	44.5 score on a scale Standard Deviation 1.3	48.4 score on a scale Standard Deviation 0.8	47.2 score on a scale Standard Deviation 1

PRIMARY outcome

Timeframe: Month 6 Post-Operation

The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
SF-12 - PCS Score at Month 6 Follow-Up	49.5 score on a scale Standard Deviation 0.9	50.1 score on a scale Standard Deviation 1.2	48.8 score on a scale Standard Deviation 1

PRIMARY outcome

Timeframe: Month 12 Post-Operation

The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
SF-12 - PCS Score at Month 12 Follow-Up	64.2 score on a scale Standard Deviation 1.7	61.6 score on a scale Standard Deviation 1.5	62.8 score on a scale Standard Deviation 0.9

PRIMARY outcome

Timeframe: Month 24 Post-Operation

The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
SF-12 - PCS Score at Month 24 Follow-Up	69.4 score on a scale Standard Deviation 0.8	67.7 score on a scale Standard Deviation 1.5	70.2 score on a scale Standard Deviation 1.2

PRIMARY outcome

Timeframe: Pre-Operation Visit (Day 0)

The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
SF-12 - Mental Component Summary (MCS) Score at Pre-Op Visit	51.9 score on a scale Standard Deviation 2.6	53.4 score on a scale Standard Deviation 1.7	55.1 score on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: Week 6 Post-Operation

The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
SF-12 - MCS Score at Week 6 Follow-Up	58.6 score on a scale Standard Deviation 1.1	57.5 score on a scale Standard Deviation 0.8	58.1 score on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Month 3 Follow-Up Post-Operation

The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
SF-12 - MCS Score at Month 3 Follow-Up	58.9 score on a scale Standard Deviation 1.5	57.7 score on a scale Standard Deviation 1.3	57.8 score on a scale Standard Deviation 1.1

PRIMARY outcome

Timeframe: Month 6 Post-Operation

The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
SF-12 - MCS Score at Month 6 Follow-Up	63.1 score on a scale Standard Deviation 1.5	65.5 score on a scale Standard Deviation 1.2	65.2 score on a scale Standard Deviation 0.9

PRIMARY outcome

Timeframe: Pre-Operation Visit (Day 0)

5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Euro-Qol 5-Dimension (EQ-5D) Score at Pre-Op Visit	10 score on a scale Standard Deviation 1.1	11 score on a scale Standard Deviation 1.3	10.5 score on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: Week 6 Post-Operation

5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
EQ-5D Score at Week 6 Follow-Up	8.4 score on a scale Standard Deviation 1.3	8.1 score on a scale Standard Deviation 0.7	9 score on a scale Standard Deviation 1.8

PRIMARY outcome

Timeframe: Month 3 Post-Operation

5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
EQ-5D Score at Month 3 Follow-Up	8 score on a scale Standard Deviation 2.5	7.9 score on a scale Standard Deviation 1.3	8.3 score on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Month 6 Post-Operation

5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
EQ-5D Score at Month 6 Follow-Up	7.6 score on a scale Standard Deviation 1.6	7.1 score on a scale Standard Deviation 1.1	7.8 score on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: Month 12 Post-Operation

5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
EQ-5D Score at Month 12 Follow-Up	6.9 score on a scale Standard Deviation 1.1	7 score on a scale Standard Deviation 1.7	7.4 score on a scale Standard Deviation 2

PRIMARY outcome

Timeframe: Month 24 Post-Operation

5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
EQ-5D Score at Month 24 Follow-Up	7.1 score on a scale Standard Deviation 1	7.4 score on a scale Standard Deviation 1.7	7 score on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: Pre-Operation Visit (Day 0)

Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Pain Catastrophizing Scale (PCS) Score at Pre-Op Visit	33.6 score on a scale Standard Deviation 2.4	35.2 score on a scale Standard Deviation 1.9	35.4 score on a scale Standard Deviation 2.8

PRIMARY outcome

Timeframe: Week 6 Post-Operation

Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PCS Score at Week 6 Follow-Up	30.4 score on a scale Standard Deviation 1.8	29.6 score on a scale Standard Deviation 2.6	31.1 score on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: Month 3 Post-Operation

Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PCS Score at Month 3 Follow-Up	21.5 score on a scale Standard Deviation 2.9	25.8 score on a scale Standard Deviation 3.4	25.2 score on a scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: Month 6 Post-Operation

Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PCS Score at Month 6 Follow-Up	20.6 score on a scale Standard Deviation 3.6	22.2 score on a scale Standard Deviation 3.1	20.4 score on a scale Standard Deviation 2.6

PRIMARY outcome

Timeframe: Month 12 Post-Operation

Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PCS Score at Month 12 Follow-Up	17.3 score on a scale Standard Deviation 2.4	19.8 score on a scale Standard Deviation 2.9	20.1 score on a scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: Month 24 Post-Operation

Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PCS Score at Month 24 Follow-Up	11.3 score on a scale Standard Deviation 2.4	14.3 score on a scale Standard Deviation 2.8	15.1 score on a scale Standard Deviation 3.1

PRIMARY outcome

Timeframe: Pre-Operation Visit (Day 0)

40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Patient Reported Outcome Measure Information System (PROMIS) Item Bank v1.1 - Pain Interference Score at Pre-Op Visit	63.2 T-score Standard Deviation 3.5	65.1 T-score Standard Deviation 3.8	60.2 T-score Standard Deviation 2.8

PRIMARY outcome

Timeframe: Week 6 Post-Operation

40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Item Bank v1.1 - Pain Interference Score at Week 6 Follow-Up	54.3 T-score Standard Deviation 2.7	51.1 T-score Standard Deviation 2.4	55.5 T-score Standard Deviation 3.3

PRIMARY outcome

Timeframe: Month 3 Post-Operation

40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Item Bank v1.1 - Pain Interference Score at Month 3 Follow-Up	50.8 T-score Standard Deviation 3.7	49.7 T-score Standard Deviation 2.5	51.4 T-score Standard Deviation 2.1

PRIMARY outcome

Timeframe: Month 6 Post-Operation

40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Item Bank v1.1 - Pain Interference Score at Month 6 Follow-Up	47.4 T-score Standard Deviation 2.4	47.6 T-score Standard Deviation 3.1	49.3 T-score Standard Deviation 2.8

PRIMARY outcome

Timeframe: Month 12 Post-Operation

40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Item Bank v1.1 - Pain Interference Score at Month 12 Follow-Up	41.3 T-score Standard Deviation 2.8	43.7 T-score Standard Deviation 2.5	43.5 T-score Standard Deviation 2.1

PRIMARY outcome

Timeframe: Month 24 Post-Operation

40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Item Bank v1.1 - Pain Interference Score at Month 24 Follow-Up	33.8 T-score Standard Deviation 2.4	32.9 T-score Standard Deviation 2.9	35.4 T-score Standard Deviation 2.1

PRIMARY outcome

Timeframe: Pre-Operation Visit (Day 0)

3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Pre-Op Visit	68.7 T-score Standard Deviation 1.8	69.5 T-score Standard Deviation 1.4	70.4 T-score Standard Deviation 2.5

PRIMARY outcome

Timeframe: Week 6 Post-Operation

3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Week 6 Follow-Up	61.3 T-score Standard Deviation 3.4	62.4 T-score Standard Deviation 2.9	60.1 T-score Standard Deviation 3.3

PRIMARY outcome

Timeframe: Month 3 Post-Operation

3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 3 Follow-Up	52.8 T-score Standard Deviation 2.7	51.9 T-score Standard Deviation 2.9	54.2 T-score Standard Deviation 3.2

PRIMARY outcome

Timeframe: Month 6 Post-Operation

3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 6 Follow-Up	50.6 T-score Standard Deviation 2.5	51.3 T-score Standard Deviation 1.9	52.8 T-score Standard Deviation 2.8

PRIMARY outcome

Timeframe: Month 12 Post-Operation

3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 12 Follow-Up	33.2 T-score Standard Deviation 1.9	35.5 T-score Standard Deviation 1.5	38.6 T-score Standard Deviation 2.3

PRIMARY outcome

Timeframe: Month 24 Post-Operation

3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 24 Follow-Up	25.3 T-score Standard Deviation 2.4	20.1 T-score Standard Deviation 2.8	23.4 T-score Standard Deviation 3.1

PRIMARY outcome

Timeframe: Pre-Operation Visit (Day 0)

120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Bank v1.2 - Physical Function Score at Pre-Op Visit	58.9 T-score Standard Deviation 2.1	60.3 T-score Standard Deviation 3.5	54.3 T-score Standard Deviation 3.1

PRIMARY outcome

Timeframe: Week 6 Post-Operation

120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Bank v1.2 - Physical Function Score at Week 6 Follow-Up	50.1 T-score Standard Deviation 2.5	52.6 T-score Standard Deviation 1.8	51.1 T-score Standard Deviation 1.6

PRIMARY outcome

Timeframe: Month 3 Post-Operation

120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Bank v1.2 - Physical Function Score at Month 3 Follow-Up	48.3 T-score Standard Deviation 2.9	47.7 T-score Standard Deviation 3.2	46.5 T-score Standard Deviation 2.6

PRIMARY outcome

Timeframe: Month 6 Post-Operation

120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Bank v1.2 - Physical Function Score at Month 6 Follow-Up	43.6 T-score Standard Deviation 2.4	44.9 T-score Standard Deviation 1.8	42.2 T-score Standard Deviation 1.7

PRIMARY outcome

Timeframe: Month 12 Post-Operation

120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Bank v1.2 - Physical Function Score at Month 12 Follow-Up	39.7 T-score Standard Deviation 1.9	42.4 T-score Standard Deviation 1.5	40 T-score Standard Deviation 1.1

PRIMARY outcome

Timeframe: Month 24 Post-Operation

120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Bank v1.2 - Physical Function Score at Month 24 Follow-Up	34.1 T-score Standard Deviation 2.3	37.3 T-score Standard Deviation 2.6	38 T-score Standard Deviation 2

PRIMARY outcome

Timeframe: Pre-Operation Visit (Day 0)

15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Bank v2.0 - Mobility Score at Pre-Op Visit	62.1 T-score Standard Deviation 2.8	60.7 T-score Standard Deviation 3.5	64.3 T-score Standard Deviation 3.2

PRIMARY outcome

Timeframe: Week 6 Post-Operation

15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Bank v2.0 - Mobility Score at Week 6 Follow-Up	53.6 T-score Standard Deviation 3.5	55 T-score Standard Deviation 2.8	56.7 T-score Standard Deviation 2.7

PRIMARY outcome

Timeframe: Month 3 Post-Operation

15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Bank v2.0 - Mobility Score at Month 3 Follow-Up	49.8 T-score Standard Deviation 2.6	51.1 T-score Standard Deviation 2.4	53 T-score Standard Deviation 2.3

PRIMARY outcome

Timeframe: Month 6 Post-Operation

15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Bank v2.0 - Mobility Score at Month 6 Follow-Up	47.2 T-score Standard Deviation 2.4	49.3 T-score Standard Deviation 2.8	49.8 T-score Standard Deviation 2.7

PRIMARY outcome

Timeframe: Month 12 Post-Operation

15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Bank v2.0 - Mobility Score at Month 12 Follow-Up	42.7 T-score Standard Deviation 2.1	44 T-score Standard Deviation 3.6	44.8 T-score Standard Deviation 2.5

PRIMARY outcome

Timeframe: Month 24 Post-Operation

15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
PROMIS Bank v2.0 - Mobility Score at Month 24 Follow-Up	39.5 T-score Standard Deviation 2.8	41.1 T-score Standard Deviation 2.4	43 T-score Standard Deviation 2.7

PRIMARY outcome

Timeframe: Intraoperative Period (Day 0) (typically between 2-7 hours)

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Length of Operation	324.6 minutes Standard Deviation 114.8	354.4 minutes Standard Deviation 125.3	315.7 minutes Standard Deviation 133.8

PRIMARY outcome

Timeframe: From admission up to discharge (Up to Year 2 Post-Operation)

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Length of Hospital Stay	7.1 Days Standard Deviation 4.1	8 Days Standard Deviation 4.4	7.3 Days Standard Deviation 3.8

PRIMARY outcome

Timeframe: Intraoperative Period (Day 0) (typically between 2-7 hours)

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Blood Loss During Procedure	845.3 Millilitres Standard Deviation 316.7	866.1 Millilitres Standard Deviation 286.4	833.6 Millilitres Standard Deviation 322.7

PRIMARY outcome

Timeframe: Pre-Operation Visit (Day 0)

Number of participants taking OTC drugs for pain relief.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Number of Participants Using Non-Prescription, Over-the-Counter (OTC) Drugs at Pre-Op Visit	20 Participants	20 Participants	19 Participants

PRIMARY outcome

Timeframe: Week 6 Post-Operation

Number of participants taking OTC drugs for pain relief.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Number of Participants Using Non-Prescription, OTC Drugs at Week 6 Follow-Up	20 Participants	20 Participants	19 Participants

PRIMARY outcome

Timeframe: Month 3 Post-Operation

Number of participants taking OTC drugs for pain relief.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Number of Participants Using Non-Prescription, OTC Drugs at Month 3 Follow-Up	17 Participants	18 Participants	18 Participants

PRIMARY outcome

Timeframe: Month 6 Post-Operation

Number of participants taking OTC drugs for pain relief.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Number of Participants Using Non-Prescription, OTC Drugs at Month 6 Follow-Up	10 Participants	12 Participants	15 Participants

PRIMARY outcome

Timeframe: Month 12 Post-Operation

Number of participants taking OTC drugs for pain relief.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Number of Participants Using Non-Prescription, OTC Drugs at Month 12 Follow-Up	9 Participants	11 Participants	12 Participants

PRIMARY outcome

Timeframe: Month 24 Post-Operation

Number of participants taking OTC drugs for pain relief.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Number of Participants Using Non-Prescription, OTC Drugs at Month 24 Follow-Up	6 Participants	8 Participants	8 Participants

PRIMARY outcome

Timeframe: Intraoperative Period (Day 0) (typically between 2-7 hours)

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Number of Participants With Surgical Complications During Operation	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Week 6 Post-Operation

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Number of Participants With Surgical Complications at Week 6 Follow-Up	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Month 3 Post-Operation

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Number of Participants With Surgical Complications at Month 3 Follow-Up	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Month 6 Post-Operation

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Number of Participants With Surgical Complications at Month 6 Follow-Up	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Month 12 Post-Operation

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Number of Participants With Surgical Complications at Month 12 Follow-Up	3 Participants	4 Participants	3 Participants

PRIMARY outcome

Timeframe: Month 24 Post-Operation

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Number of Participants With Surgical Complications at Month 24 Follow-Up	3 Participants	4 Participants	3 Participants

PRIMARY outcome

Timeframe: Month 12 Post-Operation

The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
SF-12 - MCS Score at Month 12 Follow-Up	69.4 score on a scale Standard Deviation 0.8	67.7 score on a scale Standard Deviation 2.9	68.8 score on a scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: Month 12 Post-Operation

The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.

Outcome measures

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 Participants A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 Participants 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 Participants As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
SF-12 - MCS Score at Month 24 Follow-Up	74.2 score on a scale Standard Deviation 2.4	75.6 score on a scale Standard Deviation 3.1	75.2 score on a scale Standard Deviation 2

Adverse Events

Bone Marrow Aspirate Concentrate (BMAC) + Allograft

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Recombinant Human Bone Morphogenetic Protein-2 (BMP)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Autograft

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bone Marrow Aspirate Concentrate (BMAC) + Allograft n=20 participants at risk A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.	Recombinant Human Bone Morphogenetic Protein-2 (BMP) n=20 participants at risk 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.	Autograft n=19 participants at risk As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/20 • Month 24 Post-Operation (2 years) Adverse events related to study will be detected from follow up visits by the patient and during the post-operative period by the principal investigator and co-investigators, through physical exam assessment and reviewing x-rays and CT scans of the subject.	10.0% 2/20 • Month 24 Post-Operation (2 years) Adverse events related to study will be detected from follow up visits by the patient and during the post-operative period by the principal investigator and co-investigators, through physical exam assessment and reviewing x-rays and CT scans of the subject.	5.3% 1/19 • Month 24 Post-Operation (2 years) Adverse events related to study will be detected from follow up visits by the patient and during the post-operative period by the principal investigator and co-investigators, through physical exam assessment and reviewing x-rays and CT scans of the subject.
Renal and urinary disorders Urinary Tract Infection	5.0% 1/20 • Month 24 Post-Operation (2 years) Adverse events related to study will be detected from follow up visits by the patient and during the post-operative period by the principal investigator and co-investigators, through physical exam assessment and reviewing x-rays and CT scans of the subject.	0.00% 0/20 • Month 24 Post-Operation (2 years) Adverse events related to study will be detected from follow up visits by the patient and during the post-operative period by the principal investigator and co-investigators, through physical exam assessment and reviewing x-rays and CT scans of the subject.	5.3% 1/19 • Month 24 Post-Operation (2 years) Adverse events related to study will be detected from follow up visits by the patient and during the post-operative period by the principal investigator and co-investigators, through physical exam assessment and reviewing x-rays and CT scans of the subject.
Musculoskeletal and connective tissue disorders Non-union	15.0% 3/20 • Month 24 Post-Operation (2 years) Adverse events related to study will be detected from follow up visits by the patient and during the post-operative period by the principal investigator and co-investigators, through physical exam assessment and reviewing x-rays and CT scans of the subject.	20.0% 4/20 • Month 24 Post-Operation (2 years) Adverse events related to study will be detected from follow up visits by the patient and during the post-operative period by the principal investigator and co-investigators, through physical exam assessment and reviewing x-rays and CT scans of the subject.	15.8% 3/19 • Month 24 Post-Operation (2 years) Adverse events related to study will be detected from follow up visits by the patient and during the post-operative period by the principal investigator and co-investigators, through physical exam assessment and reviewing x-rays and CT scans of the subject.

Additional Information

Themistocles Protopsaltis

NYU Langone Health

Phone: 646-501-7200

Email: themistocles.protopsaltis@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place