Efficacy and safety of recombinant human bone morphogenetic protein-2 biomaterials in promoting bone regeneration: A systematic review and meta-analysis.

OBJECTIVES

This study aims to systematically evaluate the efficacy and safety of recombinant human bone morphogenetic protein-2 (rhBMP-2) in promoting bone regeneration.

MATERIALS AND

METHODS

A comprehensive search of PubMed, Embase, Web of Science, and Scopus was conducted from inception to May 2024. Fifteen randomized-controlled trials involving 2,137 cases were included. Traditional and network meta-analyses were performed, machine learning techniques were applied to explore heterogeneity, and subgroup analyses were carried out to assess efficacy across anatomical sites including alveolar sockets, palatal clefts, and spinal fusion.

RESULTS

No significant difference was found in the overall bone healing rate between the rhBMP-2 and control groups (relative risk [RR] = 1.02, 95% confidence interval [CI] 0.87-1.20). However, rhBMP-2 demonstrated a significant advantage in spinal fusion (RR = 1.09, 95% CI 1.01-1.17) and a positive, although not statistically significant, trend in small oral and jaw bone defects. The incidence of serious adverse events was comparable (RR = 0.97, 95% CI 0.66-1.42). Network meta-analysis indicated that the overall success rate of bone regeneration with rhBMP-2 (odds ratio [OR] = 1.53, 95% CI 0.54-4.33) and other bone substitutes (OR = 1.42, 95% CI 0.39-5.21) did not significantly exceed autograft treatment, although both showed a trend toward superiority. Direct pairwise comparison revealed that rhBMP-2 was significantly more effective than autograft (OR = 1.54, 95% CI 1.02-2.33, p < 0.05), with low heterogeneity (I2 = 0%).

CONCLUSION

While the overall healing rate was comparable to controls, rhBMP-2 showed significant efficacy in spinal fusion and a favorable safety profile. Its effectiveness was context-specific, influenced by anatomical site and patient factors. These findings support the selective use of rhBMP-2 in specific clinical contexts such as spinal surgery, while further research is needed to optimize its application in other indications.