Union Rate and Complications in Spine Fusion with Recombinant Human Bone Morphogenetic Protein-7: Systematic Review and Meta-Analysis.

Abstract

Study Design Systematic review and meta-analysis. Objective The objective of this meta-analysis was to evaluate the current best evidence to assess effectiveness and safety of recombinant human bone morphogenetic protein-7 (rhBMP-7) as a biological stimulant in spine fusion. Methods Studies were included if they reported on outcomes after spine fusion with rhBMP-7. The data was synthesized using Mantel-Haenszel pooled risk ratios (RRs) with 95% confidence intervals (CIs). Main end points were union rate, overall complications, postoperative back and leg pain, revision rates, and new-onset cancer. Results Our search produced 796 studies, 6 of which were eligible for inclusion. These studies report on a total of 442 patients (328 experimental, 114 controls) with a mean age of 59 ± 11 years. Our analysis showed no statistically significant differences in union rates (RR 0.97, 95% CI 0.84 to 1.11, p = 0.247), overall complications (RR 0.92, 95% CI 0.71 to 1.20, p = 0.545), postoperative back and leg pain (RR 1.03, 95% CI 0.48 to 2.19, p = 0.941), or revision rate (RR 0.81, 95% CI 0.47 to 1.40, p = 0.449). There was a mathematical indicator of increased tumor rates, but with only one case, the clinical meaningfulness of this finding is questionable. Conclusion We were not able to find data in support of the use of rhBMP-7 for spine fusion. We found no evidence for increased complication or revision rates with rhBMP-7. On the other hand, we also found no evidence in support of improved union rates.