Usage Trends and Safety Profile of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Column Tumor Surgery: A National Matched Cohort Analysis
Global spine journal(2023)
摘要
STUDY DESIGN:Retrospective Cohort Analysis.OBJECTIVE:The purpose of this study is to investigate national rates of rhBMP-2 utilization in spinal tumor surgery and examine its association with postoperative complications, revisions, and carcinogenicity.METHODS:All patients diagnosed with primary or metastatic spinal tumors with subsequent surgical intervention involving a spinal fusion procedure were identified in PearlDiver. Patients were 1:1 matched into 2 cohorts according to rhBMP-2 usage. Postoperative complications and revisions were examined at 1 month, 3 months, 6 months, and 1 year after fusion. New cancer incidence following spinal tumor surgery was assessed until 5 years postoperatively.RESULTS:A total of 11,198 patients underwent fusion surgery after resection of spinal tumors between 2005 and 2020, with 909 cases reporting the use of rhBMP-2 (8.1%). An annualized analysis revealed that the proportion of spine tumor fusion procedures utilizing rhBMP-2 has been significantly decreasing (R2 = .859, P < .001), with the most recent annual utilization rate at 1.1%. At least 3 months after surgery, significantly increased incidences of surgical site (11.4% vs 3.3%, P = .03) and systemic infections (8.1% vs 1.6%, P = .02) were observed in patients who underwent fusion with rhBMP-2. Across all time points, no significant differences were observed in survival, implant removal, revision rates, or new cancer diagnoses.CONCLUSION:This analysis demonstrated significantly declining national utilization rates. Spinal tumor cases utilizing rhBMP-2 sustained greater rates of surgical site and systemic infections. rhBMP-2 usage did not significantly reduce the risk of mortality, implant failure, or reoperation.
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关键词
bone graft,fusion,tumor,tumors,metastases,basic science,bone morphogenetic protein
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