Lumbar Degenerative Disc Disease Clinical Trial
— BMACOfficial title:
Prospective Study of Thoracolumbar Spinal Fusion Graft Efficacy: Bone Marrow Aspirate Concentrate Versus Iliac Crest Bone Graft
Verified date | September 2023 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 17 |
Est. completion date | December 1, 2025 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Center for Musculoskeletal Care (CMC) | New York | New York |
United States | NYU Hospital for Joint Diseases | New York | New York |
United States | NY Spine Institute | Westbury | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CT scan to assess fusion status | Pre-operative, Post Operative 1 Year | ||
Primary | Oswestry Disability Index (ODI) | Pre-operative, Post Operative 1 Year | ||
Primary | Short Form Health Survey (SF-12) | Pre-op, Post Operative 1 Year | ||
Primary | Numeric Pain Rating Scale | Pre-op, Post Operative 1 Year | ||
Primary | Length of Stay | Post Operative 1 Year |
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