1074 A Prospective, Post Market, Multi-center, Open Label, Non-randomized Clinical Study of the Efficacy of Using a Cellular Bone Allograft (CBA) in Lumbar Fusion Surgery

Abstract

INTRODUCTION: Autologous bone grafting contains the osteoconductive, osteoinductive and osteogenic elements essential for bone healing in patients at a high-risk for nonunion. There is a lack of prospective lumbar fusion studies with comprehensive and objective outcome assessments that utilize alternatives to iliac crest bone grafting. METHODS: This analysis includes subjects with complete clinical and radiographic outcomes at 12-months (n = 221), and 24-months (n = 199) follow-up. Fusion was determined by independent review, characterizing motion (=3° and =3mm) from flexion/extension X-rays, AND the presence of bridging bone via CT. RESULTS: The mean age of the study cohort was 58.8 years with 63% being female, and a mean BMI of 30.7. Regarding the subjects reporting of risk-factors to bone healing (e.g., multilevel disease, BMI, nicotine use, diabetes), 86.5% of subjects reported at least a single risk factor, with 49% (n = 99) of subjects reporting multiple risk-factors to bone healing. Fusion success rates were 91.4% (202/221) at 12-months, and 91.9% (183/199) at 24-months. Patient reported outcomes included VAS Back and Leg Pain, ODI, and EQ-5D. Mean ODI significantly improved by 22.1 (p < 0.001) and 22.7 (p < 0.001) points from baseline at 12 and 24-months respectively. Back pain scores decreased significantly from baseline: 57.47 (28.62) to 18.46 (24.86) at 12 months, and 12.02 (21.01) at 24 months. VAS leg pain also significantly decreased from baseline to 12 and 24 months, with an overall decrease in mean score of 27.54 and 32.09 respectively. CONCLUSIONS: These study findings provide additional support for the viability and efficacy of CBAs in spinal fusion. The fusion rates observed in this study are comparable to ICBG fusion rates reported in the literature.