Exploratory meta-analysis on dose-related efficacy and complications of rhBMP-2 in anterior cervical discectomy and fusion: 1,539,021 cases from 2003 to 2017 studies

Abstract

s Background/Objective Anterior cervical discectomy and fusion (ACDF), commonly using autogenous iliac bone graft may be limited by donor site availability, donor-site morbidity, lower fusion rate among specific patients and longer surgical time. Surgeons used rhBMP-2 as an alternative in order to fill these clinical needs. However, studies comparing with and without rhBMP-2 in ACDF have reported conflicting results on efficacy and complications. Therefore, the purpose of this article was to evaluate efficacy and complications through dose-related rhBMP-2 and surgical level-dependence in ACDF. Methods We comprehensively searched PubMed and the Cochrane Library and performed a systematic review and cumulative meta-analysis of all randomized controlled trials (RCTs), prospective and retrospective comparative studies assessing with and without rhBMP-2 treatments. Results 1 RCTs, 4 prospective studies and 24 retrospective studies including a total of 1,539,021 cases were identified. Patients in ACDF with rhBMP-2 might benefit from significantly higher fusion rates than that in non-rhBMP-2, not only total value but also in 3 tiers of rhBMP-2 doses. It is worth noting that the low dose of rhBMP-2 (<0.7 mg/level) showed highest fusion rate among all rhBMP-2 doses. Patients in rhBMP-2 also experienced higher complication rate, dysphagia and wound infections than that in non-rhBMP-2. In 2-level ACDF, the fusion rate was significantly better in rhBMP-2 than non-rhBMP-2 but not for complication rate. Surgery operative time, lengths of hospital stay and neurologic symptoms did not differ significantly between two treatments. Conclusions rhBMP-2 chosen in ACDF offered higher fusion, but also higher complication rate with more dysphagia and wound infections than non-rhBMP-2. To gain the efficacy and safety, rhBMP-2 dosing recommendations for ACDF would be better < 0.7 mg/level. Moreover, rhBMP-2 may be an option to improve nonunion in high risk of multi-level ACDF. The translational potential of this article This article indicated that the product development of facilities used in ACDF, the dose of rhBMP-2 may be lower than 0.7 mg/level was enough to gain the good fusion rates. However, the complications were higher in patients used rhBMP-2, therefore the manufacturers should pay attention to mitigate such side effects.

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