Trial Outcomes & Findings for Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease (NCT NCT03733626)
NCT ID: NCT03733626
Last Updated: 2025-06-26
Results Overview
Count of participants with successful lumbar bone fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no presence of radiolucency and no development of pseudoarthrosis at the treated lumbar level
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
12 months postoperative
Results posted on
2025-06-26
Participant Flow
2 patients were consented but screen failure prior to randomization, leaving 44 patients at start of study
Participant milestones
| Measure |
ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System
20 subjects undergoing one or two-level instrumented posterolateral lumbar fusion surgery using ViviGen Cellular Bone Matrix mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system: ViviGen® is manufactured by LifeNet Health. ViviGen® Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone.
|
Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System
20 subjects undergoing open, one or two-level posterolateral lumbar fusion surgery using local autograft mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system.
Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system: Patient's own bone harvested during spinal surgery will be used with the FDA approved DePuy Synthes spinal pedicle screw system to create the fusion.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System
20 subjects undergoing one or two-level instrumented posterolateral lumbar fusion surgery using ViviGen Cellular Bone Matrix mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system: ViviGen® is manufactured by LifeNet Health. ViviGen® Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone.
|
Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System
20 subjects undergoing open, one or two-level posterolateral lumbar fusion surgery using local autograft mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system.
Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system: Patient's own bone harvested during spinal surgery will be used with the FDA approved DePuy Synthes spinal pedicle screw system to create the fusion.
|
|---|---|---|
|
Overall Study
Physician Decision
|
4
|
4
|
Baseline Characteristics
Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease
Baseline characteristics by cohort
| Measure |
ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System
n=19 Participants
20 subjects undergoing one or two-level instrumented posterolateral lumbar fusion surgery using ViviGen Cellular Bone Matrix mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system: ViviGen® is manufactured by LifeNet Health. ViviGen® Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone.
|
Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System
n=17 Participants
20 subjects undergoing open, one or two-level posterolateral lumbar fusion surgery using local autograft mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system.
Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system: Patient's own bone harvested during spinal surgery will be used with the FDA approved DePuy Synthes spinal pedicle screw system to create the fusion.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months postoperativeCount of participants with successful lumbar bone fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no presence of radiolucency and no development of pseudoarthrosis at the treated lumbar level
Outcome measures
| Measure |
ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System
n=19 Participants
20 subjects undergoing one or two-level instrumented posterolateral lumbar fusion surgery using ViviGen Cellular Bone Matrix mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system: ViviGen® is manufactured by LifeNet Health. ViviGen® Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone.
|
Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System
n=17 Participants
20 subjects undergoing open, one or two-level posterolateral lumbar fusion surgery using local autograft mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system.
Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system: Patient's own bone harvested during spinal surgery will be used with the FDA approved DePuy Synthes spinal pedicle screw system to create the fusion.
|
|---|---|---|
|
Incidence of Successful Lumbar Fusion Measured Radiographically
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 12 months postoperativePopulation: 4 subjects in autograft arm and 3 subjects in the ViviGen arm did not have 12 month data.
Number of participants achieving equal to or greater than a 2-point decrease in patient reported outcomes as measured by Visual Analog Scale for pain (0-10 point scale, 0 = no pain and 10 = severe amount of pain) from baseline to 12-months, representing a decrease in pain.
Outcome measures
| Measure |
ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System
n=16 Participants
20 subjects undergoing one or two-level instrumented posterolateral lumbar fusion surgery using ViviGen Cellular Bone Matrix mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system: ViviGen® is manufactured by LifeNet Health. ViviGen® Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone.
|
Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System
n=13 Participants
20 subjects undergoing open, one or two-level posterolateral lumbar fusion surgery using local autograft mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system.
Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system: Patient's own bone harvested during spinal surgery will be used with the FDA approved DePuy Synthes spinal pedicle screw system to create the fusion.
|
|---|---|---|
|
Visual Analog Scale for Pain
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 12 months postoperativePopulation: 3 participants in the ViviGen group and 4 participants in the Autograft group did not have 12 month data collected
Number of participants achieving equal to or greater than 15-point decrease in patient reported outcomes as measured by Oswestry Disability Index (0-100 point scale, 0 = least amount of disability, 100 = most severe disability) from baseline to 12-months.
Outcome measures
| Measure |
ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System
n=16 Participants
20 subjects undergoing one or two-level instrumented posterolateral lumbar fusion surgery using ViviGen Cellular Bone Matrix mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system: ViviGen® is manufactured by LifeNet Health. ViviGen® Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone.
|
Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System
n=13 Participants
20 subjects undergoing open, one or two-level posterolateral lumbar fusion surgery using local autograft mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system.
Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system: Patient's own bone harvested during spinal surgery will be used with the FDA approved DePuy Synthes spinal pedicle screw system to create the fusion.
|
|---|---|---|
|
Change in Oswestry Disability Index for Pain and Function
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 12 months postoperativePopulation: 4 participants in the ViviGen group and 4 participants in the Autograft group did not complete12 month SF-36 data
Number of participants achieving equal to or greater than 15-point increase in patient reported quality-of-live outcomes as measured by a composite Physical Component Summary score on the SF-36 (0-100 point scale, 0 = low favorable health state and 100 = most favorable health state) from baseline to 12-months. This Physical Component Summary score is calculated by averaging scores from the Pain, Physical Functioning, Physical Role Limitation, and General Health Perception subscales for each patient at 12 months and at baseline, and calculating a difference. A positive number indicates an increase in physical health, and a negative number indicates a decrease in physical health.
Outcome measures
| Measure |
ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System
n=15 Participants
20 subjects undergoing one or two-level instrumented posterolateral lumbar fusion surgery using ViviGen Cellular Bone Matrix mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system: ViviGen® is manufactured by LifeNet Health. ViviGen® Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone.
|
Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System
n=13 Participants
20 subjects undergoing open, one or two-level posterolateral lumbar fusion surgery using local autograft mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system.
Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system: Patient's own bone harvested during spinal surgery will be used with the FDA approved DePuy Synthes spinal pedicle screw system to create the fusion.
|
|---|---|---|
|
Change in Short Form Health Survey-36 for Quality of Life: Physical Component Summary
|
12 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 months postoperativePopulation: 7 participants in the ViviGen Cellular Bone Matrix arm did not complete the 12 month postoperative visit and no data was collected. 5 participants in the local bone autograft arm did not complete the 12 month postoperative visit and no data was collected.
Count of participants with new or worsening neurological (lumbar motor and sensory) deficit as evaluated by lumbar spine neurological exam from baseline through 12 months.
Outcome measures
| Measure |
ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System
n=12 Participants
20 subjects undergoing one or two-level instrumented posterolateral lumbar fusion surgery using ViviGen Cellular Bone Matrix mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system: ViviGen® is manufactured by LifeNet Health. ViviGen® Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone.
|
Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System
n=12 Participants
20 subjects undergoing open, one or two-level posterolateral lumbar fusion surgery using local autograft mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system.
Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system: Patient's own bone harvested during spinal surgery will be used with the FDA approved DePuy Synthes spinal pedicle screw system to create the fusion.
|
|---|---|---|
|
Neurological Deficit Per Lumbar Spine Neurological Exam
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 months postoperativeCount of participants with revision surgery by month 12
Outcome measures
| Measure |
ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System
n=19 Participants
20 subjects undergoing one or two-level instrumented posterolateral lumbar fusion surgery using ViviGen Cellular Bone Matrix mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system: ViviGen® is manufactured by LifeNet Health. ViviGen® Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone.
|
Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System
n=17 Participants
20 subjects undergoing open, one or two-level posterolateral lumbar fusion surgery using local autograft mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system.
Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system: Patient's own bone harvested during spinal surgery will be used with the FDA approved DePuy Synthes spinal pedicle screw system to create the fusion.
|
|---|---|---|
|
Count of Participants With Revision Surgery by Month 12
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months postoperativeCount of participants developing pseudoarthrosis by month 12
Outcome measures
| Measure |
ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System
n=19 Participants
20 subjects undergoing one or two-level instrumented posterolateral lumbar fusion surgery using ViviGen Cellular Bone Matrix mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system: ViviGen® is manufactured by LifeNet Health. ViviGen® Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone.
|
Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System
n=17 Participants
20 subjects undergoing open, one or two-level posterolateral lumbar fusion surgery using local autograft mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system.
Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system: Patient's own bone harvested during spinal surgery will be used with the FDA approved DePuy Synthes spinal pedicle screw system to create the fusion.
|
|---|---|---|
|
Count of Participants Developing Pseudoarthrosis by Month 12
|
0 Participants
|
1 Participants
|
Adverse Events
ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System
n=19 participants at risk
20 subjects undergoing one or two-level instrumented posterolateral lumbar fusion surgery using ViviGen Cellular Bone Matrix mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system: ViviGen® is manufactured by LifeNet Health. ViviGen® Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone.
|
Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System
n=17 participants at risk
20 subjects undergoing open, one or two-level posterolateral lumbar fusion surgery using local autograft mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system.
Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system: Patient's own bone harvested during spinal surgery will be used with the FDA approved DePuy Synthes spinal pedicle screw system to create the fusion.
|
|---|---|---|
|
Cardiac disorders
Cardiac vessel occlusion
|
5.3%
1/19 • Number of events 1 • 12 months
|
0.00%
0/17 • 12 months
|
Other adverse events
| Measure |
ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System
n=19 participants at risk
20 subjects undergoing one or two-level instrumented posterolateral lumbar fusion surgery using ViviGen Cellular Bone Matrix mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system: ViviGen® is manufactured by LifeNet Health. ViviGen® Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone.
|
Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System
n=17 participants at risk
20 subjects undergoing open, one or two-level posterolateral lumbar fusion surgery using local autograft mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system.
Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system: Patient's own bone harvested during spinal surgery will be used with the FDA approved DePuy Synthes spinal pedicle screw system to create the fusion.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.8%
3/19 • Number of events 3 • 12 months
|
23.5%
4/17 • Number of events 4 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Sacroiliac joint pain
|
0.00%
0/19 • 12 months
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pseuroarthrosis L4-5
|
0.00%
0/19 • 12 months
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
0.00%
0/19 • 12 months
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/19 • 12 months
|
11.8%
2/17 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
0.00%
0/19 • 12 months
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Dural Tear, intraoperative
|
0.00%
0/19 • 12 months
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Nervous system disorders
neurogenic claudication
|
0.00%
0/19 • 12 months
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Nervous system disorders
cervical radiculopathy
|
0.00%
0/19 • 12 months
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Nervous system disorders
Lower extremity numbness/weakness
|
5.3%
1/19 • Number of events 1 • 12 months
|
11.8%
2/17 • Number of events 3 • 12 months
|
|
Nervous system disorders
Lower extremity pain
|
5.3%
1/19 • Number of events 1 • 12 months
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Nervous system disorders
Lower extremity radiculopathy
|
10.5%
2/19 • Number of events 2 • 12 months
|
0.00%
0/17 • 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • Number of events 1 • 12 months
|
11.8%
2/17 • Number of events 2 • 12 months
|
|
Infections and infestations
COVID-19 infection
|
5.3%
1/19 • Number of events 1 • 12 months
|
0.00%
0/17 • 12 months
|
|
Infections and infestations
Surgical site infection
|
5.3%
1/19 • Number of events 1 • 12 months
|
0.00%
0/17 • 12 months
|
|
Gastrointestinal disorders
Gastroparesis
|
5.3%
1/19 • Number of events 1 • 12 months
|
0.00%
0/17 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place