Prospective Study of Thoracolumbar Spinal Fusion Graft
- Conditions
- Lumbar Degenerative Disc Disease
- Registration Number
- NCT02297256
- Lead Sponsor
- NYU Langone Health
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 17
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method CT scan to assess fusion status Pre-operative, Post Operative 1 Year Oswestry Disability Index (ODI) Pre-operative, Post Operative 1 Year Short Form Health Survey (SF-12) Pre-op, Post Operative 1 Year Length of Stay Post Operative 1 Year Numeric Pain Rating Scale Pre-op, Post Operative 1 Year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
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
NYU Hospital for Joint Diseases🇺🇸New York, New York, United States