Efficacy of Biphasic Calcium Phosphate Ceramic With a Needle-Shaped Surface Topography Versus Autograft in Instrumented Posterolateral Spinal Fusion

Study Design. A multicenter randomized controlled noninferiority trial with intrapatient comparisons. Objective. The aim of this study was to determine noninferiority of a slowly resorbable biphasic calcium phosphate with submicron microporosity (BCP15% inferiority with binomial paired comparisons of the fusion performance score per treatment side. Results. Of the 100 patients (57 ± 12.9 y, 62% female), 91 subjects and 128 segments were analyzed. The overall posterolateral fusion rate per segment (left and/or right) was 83%. For the BCP<μm side only the fusion rate was 79% versus 47% for the autograft side (difference of 32 percentage points, 95% CI, 23-41). Analysis of the primary outcome confirmed the noninferiority of BCP<μm with an absolute difference in paired proportions of 39.6% (95% CI, 26.8-51.2; p < 0.001). Conclusion. This clinical trial demonstrates noninferiority and indicates superiority of MagnetOs Granules as a standalone ceramic when compared to autograft for posterolateral spinal fusion. These results challange the belief that autologous bone is the most optimal graft material.