Twenty-four-month interim results from a prospective clinical trial evaluating the performance and safety of a cellular bone allograft in patients undergoing lumbar spinal fusion

Abstract

Autologous bone grafts are the gold standard for spinal fusion, however harvesting autologous bone can result in donor site infection, haematomas, increased operative time, and prolonged pain. Cellular bone allografts (CBAs) are an alternative that avoids the need for bone harvesting, and may increase fusion success. The present study examined the efficacy and safety of CBA when used as an adjunct to lumbar arthrodesis. A prospective multicenter clinical trial was conducted in adult patients undergoing lumbar spinal fusion with CBA. Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcomes were assessed with the Oswestry Disability Index (ODI), and visual analog scales (VAS) for back and leg pain. Adverse events were assessed through the 24-month follow-up. The presented data represents an analysis of available patients (N = 86) at 24-months follow-up. Successful fusion was achieved in 95.3% of patients. Clinical outcomes showed statistically significant improvements from baseline in ODI, VAS-Back, and VAS-Leg outcome measures. No patient characteristics or surgical factors were associated with pseudoarthrosis. The use of CBA resulted in a high rate of successful lumbar arthrodesis. Clinical outcomes demonstrated significant improvements in pain and disability.