Background:

To investigate the clinical safety and efficacy of ViBone^® Viable Bone Matrix (VBM), a next generation cellular bone matrix allograft that comprises all three essential bone-forming components: osteogenic, osteoinductive, and osteoconductive factors, and is optimized to enhance cell viability and bone formation.

Methods:

This was a multi-center, prospective, post-market study evaluating the safety and efficacy of ViBone VBM in patients undergoing 1-3 level anterior cervical discectomy and fusion or lumbar interbody fusion surgery. Patients were evaluated at baseline, 6-month, and 12-month follow-up clinically and radiographically. Clinical assessment included Visual Analog Scale for pain (VAS-pain), the Neck Disability Index (NDI) for patients with cervical pathologies, and the Oswestry Disability Index (ODI) for patients with lumbar pathologies. Fusion success defined by an independent radiologist was determined radiographically by plain films.

Results:

Clinical outcomes evaluated with VAS-pain, NDI, and ODI scales were improved significantly at 6 and 12 months compared to baseline. All patients reached clinically significant improvements at 12 months. There were no adverse events or infections attributed to ViBone VBM. At 12 months, the fusion rate per patient was 88.1% in cervical and 97.6% in lumbar patients, while per-level fusion was 98.5% for cervical and 100% for lumbar segments.

Conclusions:

Patients undergoing cervical and lumbar spinal fusion implanted with ViBone VBM demonstrated favorable outcomes at 6 months and 12 months as measured by subjective clinical measures and radiographic fusion rates. Trial registration This study was registered as NCT03425682 on 1/29/2018.