Prospective Study of Thoracolumbar Spinal Fusion Graft

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