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

• Main Authors: Ya-Dan Wen, Wei-Min Jiang, Hui-Lin Yang, Jin-Hui Shi
• Format: Article
• Language: English
• Published: Elsevier 2020-09-01
• Series: Journal of Orthopaedic Translation
• Subjects: Anterior cervical discectomy and fusion; Efficacy and complications; Infuse® bone graft; Meta-analysis; Recombinant human bone morphogenetic protein-2; Spinal fusion
• Online Access: http://www.sciencedirect.com/science/article/pii/S2214031X20300024

Abstracts: 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.