Trial results for a study comparing bone marrow aspirate concentrate (BMAC) and allograft to iliac crest bone grafts (ICBG) in patients with Lumbar Degenerative Disc Disease were posted on ClinicalTrials.gov on 2026-04-30. The BMAC & allograft group showed a mean spinal fusion grade of 1.67 at 1 year.
Background
Degenerative Disc Disease is a common condition characterized by the breakdown of intervertebral discs, leading to pain and reduced mobility. When conservative treatments fail, spinal fusion surgery is often performed to stabilize the spine and alleviate symptoms. This procedure typically involves using bone grafts to encourage the vertebrae to fuse together. Iliac crest bone grafts (ICBG) have long been considered a gold standard due to their osteoinductive and osteoconductive properties, but their harvest can be associated with donor site morbidity. Exploring alternative graft materials like bone marrow aspirate concentrate (BMAC) combined with allograft aims to achieve similar fusion rates while potentially reducing complications.
Trial design
This completed study (Phase NA) enrolled 17 participants with Lumbar Degenerative Disc Disease. The trial was a single-center, prospective randomized clinical study designed to compare the efficacy of bone marrow aspirate concentrate (BMAC) combined with allograft to iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion. The study evaluated outcomes including spinal fusion grade, functional disability, and pain.
Key results
Key measurements from the study included:
- For Spinal Fusion Grade at 1 Year Via CT Scan (score on a scale):
- The BMAC & Allograft group had a mean score of 1.67 (Standard Deviation 0.98).
- The Iliac Crest Bone Graft group had a mean score of 2.4 (Standard Deviation 1.52).
- For Change in Oswestry Disability Index (ODI) Score (percent change):
- The BMAC & Allograft group showed a mean change of -24.
- The Iliac Crest Bone Graft group showed a mean change of -43.
- For Short Form Health Survey (SF-12) (score on a scale):
- The BMAC & Allograft group had a mean score of 5.11 (Standard Deviation 6.92).
- The Iliac Crest Bone Graft group had a mean score of 3.87 (Standard Deviation 5.86).
- For Change in Numeric Pain Rating Scale Score From Baseline (Pre-op) and 1 Year Post Operative (score on a scale):
- The BMAC & Allograft group showed a mean change of -2.58 (Standard Deviation 1.88).
- The Iliac Crest Bone Graft group showed a mean change of -1.8 (Standard Deviation 3.11).
- For Length of Stay in Hospital, Measured in Days:
- The BMAC & Allograft group had a mean stay of 5.08 Days (Standard Deviation 1.62).
- The Iliac Crest Bone Graft group had a mean stay of 5.4 Days (Standard Deviation 1.52).
What this means
The posted results provide comparative data on two different bone graft strategies for spinal fusion in degenerative disc disease. The BMAC & Allograft group demonstrated a lower mean spinal fusion grade of 1.67 compared to 2.4 for the Iliac Crest Bone Graft group, suggesting potentially improved fusion outcomes with the BMAC approach. Additionally, patients receiving BMAC & Allograft had a shorter mean hospital stay of 5.08 days versus 5.4 days for ICBG, and a greater mean reduction in pain score (-2.58 vs -1.8). However, the ICBG group showed a larger mean reduction in the Oswestry Disability Index (ODI) score (-43 vs -24), indicating a greater improvement in functional disability for that group. These findings suggest that while BMAC & Allograft may offer advantages in fusion success and some patient-reported outcomes, further research is needed to fully understand the overall clinical benefits and trade-offs compared to traditional ICBG, especially given the mixed results in functional improvement.
Source
The information for these trial results was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT02297256, titled "Prospective Study of Thoracolumbar Spinal Fusion Graft", were posted on 2026-04-30 on clinicaltrials.gov.