N/A
Completed N=17
Prospective Study of Thoracolumbar Spinal Fusion Graft
Source: ClinicalTrials.gov NCT02297256 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Spinal Fusion Grade at 1 Year Via CT Scan — 1.67; 2.4 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spinal Fusion Grade at 1 Year Via CT Scan |
1.67; 2.4 | — |
| PRIMARY Change in Oswestry Disability Index (ODI) Score |
-24; -43 | — |
| PRIMARY Short Form Health Survey (SF-12) |
5.11; 3.87 | — |
| PRIMARY Change in Numeric Pain Rating Scale Score From Baseline (Pre-op) and 1 Year Post Operative |
-2.58; -1.8 | — |
| PRIMARY Length of Stay in Hospital, Measured in Days |
5.08; 5.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02297256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.