Discussion
pain/disability, infections, NDI, pain
ADVERSE EVENTS, INFECTIONS, SPINAL INSTABILITY
Spinal fusion is a common procedure used to treat many conditions causing spinal instability. ICBG has been the gold standard graft for spinal fusion because it possesses osteoconductive, osteoinductive, and osteogenic qualities that are necessary for bone arthrodesis. However, ICBG harvest is associated with a second operative site, pain, and morbidity [Recombinant human bone morphogenetic protein-2 (rhBMP-2, Infuse Bone Graft, Medtronic, Memphis, TN) is commonly used and reported to yield high spinal fusion rates without the need for ICBG harvest. However it has also been reported to be associated with significant adverse events from various publications, most notably the Yale University Open Data Access (YODA) Project [The ability of a bone graft to successfully form new bone (osteogenesis) requires the presence of viable bone-forming cells [The primary aim of this study was to assess the safety and effectiveness of ViBone VBM in cervical and lumbar fusion procedures. To our knowledge, this is the first study reporting results of a VBM used separately in both cervical and lumbar procedures. Solid fusion at 12 months was achieved in 88.1% cervical and 97.6% lumbar patients (98.5% and 100% of levels, respectively). Furthermore, all subjective clinical assessments (VAS-pain, NDI, ODI) exhibited significant improvements at both 6- and 12-month assessments compared to baseline, and all patients reached clinically significant improvements at 12 months. The use of ViBone was not associated with any adverse events or infections and circumvented the need for harvesting ICBG, which highlights the safety of this VBM for spinal fusion procedures.Our results align with previously published spinal fusion rates for ICBG, and pain/disability scores in spinal fusion studies assessing similar numbers of patients with radiographic imaging and clinician assessments as the main evaluation tools [Similar to other studies, our results suggest that VBMs are a promising alternative to ICBG, producing comparable high fusion rates, and no associated adverse events or need for ICBG harvesting. In addition to ViBone, two other commercially available VBMs, Fiber VBM and OsteGro VBM, are also processed by the same manufacturer (Aziyo Biologics, Silver Spring, MD) with a focus on minimized apoptosis, enhanced cell–matrix preservation, and optimized handling characteristics. These minimally processed formulations are designed to improve cellular health and provide higher levels of growth factors to stimulate early and later stage bone formation.Limitations of this study include the lack of control group(s) and randomization. Also, the variety of surgical techniques and use of other bone graft materials in addition to ViBone may have influenced observed outcomes. Larger studies with longer-term follow-up are necessary to further evaluate the safety and efficacy of ViBone VBM in surgical spine patients.
