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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
17
Use of Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest during posterior lumbar/lumbosacral spinal fusion.
Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.
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
CT scan to assess fusion status
Time frame: Pre-operative, Post Operative 1 Year
Oswestry Disability Index (ODI)
Time frame: Pre-operative, Post Operative 1 Year
Short Form Health Survey (SF-12)
Time frame: Pre-op, Post Operative 1 Year
Numeric Pain Rating Scale
Time frame: Pre-op, Post Operative 1 Year
Length of Stay
Time frame: Post Operative 1 Year
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