Prospective Study of Thoracolumbar Spinal Fusion Graft

NCT ID: NCT02297256

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2025-12-01

Brief Summary

This study is a single-center, prospective randomized clinical study intended to compare and evaluate the efficacy of subjects who are treated with bone marrow aspirate concentrate (BMAC) and allograft to iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.

Detailed Description

Subjects who are candidates for posterior lumbar or lumbosacral spinal fusion without anterior interbody support will be screened for inclusion in the study. Participants will be enrolled and randomized to either the BMAC + allograft or ICBG group. An enrollment ratio of two BMAC + allograft to one ICBG subject (2:1) for up to a total of 40 subjects will be enrolled in the study which also accounts for failed screening subjects. The study will determine and compare differences in fusion rate and health related quality of life parameters at 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively.

Conditions

Lumbar Degenerative Disc Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

BMAC & Allograft

Subjects will be treated with bone marrow aspirate concentrate (BMAC) and allograft during posterior lumbar/lumbosacral spinal fusion. During lumbar spine surgery, 12 teaspoons of bone marrow will be taken (aspirated) from one side of hip bone. This may be repeated on the other side of hip bone for a total of 12, 24, or 36 teaspoons of bone marrow total taken from your hip bone depending on the decision made by the surgeon. The bone marrow will then be concentrated with a machine for 15 minutes to a final volume of 2, 4, or 6 teaspoons of BMAC. BMAC will be combined with packed allograft bone chips using another machine to produce two or three constructed bone logs. The bone logs will be laid along the backside of the spine and between each vertebral body.

Group Type: ACTIVE_COMPARATOR

BMAC & Allograft

Intervention Type: PROCEDURE

Use of Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest during posterior lumbar/lumbosacral spinal fusion.

Iliac Crest Bone Graft

Subjects who are in the Iliac Crest Bone Graft arm will be treated with Iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion. During lumbar spine surgery, the surgeon will make an incision to expose the iliac crest (hip bone), and cutting out the segments of the bone that will be needed, based on the decision of the surgeon. The bone chips will be laid along the backside of the spine and also between each vertebral body where the bone will fuse into place. When the bone becomes solid/fused, there is no movement in the fused spine.

Group Type: ACTIVE_COMPARATOR

Iliac Crest Bone Graft

Intervention Type: PROCEDURE

Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.

Interventions

BMAC & Allograft

Use of Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest during posterior lumbar/lumbosacral spinal fusion.

Intervention Type: PROCEDURE

Iliac Crest Bone Graft

Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.

Intervention Type: PROCEDURE

Other Intervention Names

Bone Marrow Aspirate Concentrate & Allograft; ICBG

Eligibility Criteria

Inclusion Criteria

• Must be 18 years old or older
• Scheduled for elective posterior spinal fusion of the thoracolumbar spine or lumbar spine with or without anterior interbody support
• Failed at least 6 weeks of conservative care
• ODI v2.1 score > 30%
• No contraindication to BMAC (as per manufacturer)
• Signed consent form

Exclusion Criteria

• Spondylolisthesis grade ≥ 3
• Pagets disease, osteomalacia, or any metabolic bone disease
• Use of medications that interfere with bone healing (chronic steroids)
• Patient unlikely to comply with post-op schedule with physician
• Recent history of chemical dependency
• Participation in other investigational device trial(s) within past 30 days
• Active malignancy
• Pregnancy or planning to become pregnant
• Direct involvement in execution of this protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Passias, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

NYU Hospital for Joint Diseases

New York, New York, United States

Center for Musculoskeletal Care (CMC)

New York, New York, United States

NY Spine Institute

Westbury, New York, United States

Countries

United States

References

Asahara T, Masuda H, Takahashi T, Kalka C, Pastore C, Silver M, Kearne M, Magner M, Isner JM. Bone marrow origin of endothelial progenitor cells responsible for postnatal vasculogenesis in physiological and pathological neovascularization. Circ Res. 1999 Aug 6;85(3):221-8. doi: 10.1161/01.res.85.3.221.

Reference Type: BACKGROUND

PMID: 10436164 (View on PubMed)

Gan Y, Dai K, Zhang P, Tang T, Zhu Z, Lu J. The clinical use of enriched bone marrow stem cells combined with porous beta-tricalcium phosphate in posterior spinal fusion. Biomaterials. 2008 Oct;29(29):3973-82. doi: 10.1016/j.biomaterials.2008.06.026. Epub 2008 Jul 18.

Reference Type: BACKGROUND

PMID: 18639333 (View on PubMed)

Other Identifiers

12-02411

Identifier Type: -

Identifier Source: org_study_id