Prospective Study of Thoracolumbar Spinal Fusion Graft

Prospective Study of Thoracolumbar Spinal Fusion Graft Efficacy: Bone Marrow Aspirate Concentrate Versus Iliac Crest Bone Graft

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.

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