Object. The author reports the clinical and radiographic outcomes obtained in three prospective multicenter clinical trials in which recombinant human bone morphogenetic protein—2 (rhBMP-2) was used in anterior lumbar interbody fusion (ALIF).
Methods. Stand-alone interbody fusion cages were used, and supplemental fixation was not performed as part of the study protocol. Patients were randomly assigned to one of two ALIF groups: one in which autologous iliac crest bone graft was used (control) and one in which an rhBMP-2—coated absorbable collagen sponge was placed (investigational group). In all patients who underwent rhBMP-2—augmented fusion, imaging demonstrated evidence of bone induction and early incorporation of the cortical allografts. Overall, more expedient clinical improvements and higher success rates were observed in the rhBMP-2 group.
Conclusions. In these studies it was shown that rhBMP-2 is a safe and effective material for facilitating ALIF and for decreasing pain and improving clinical outcomes.