Usage Trends and Safety Profile of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Column Tumor Surgery: A National Matched Cohort Analysis.

Abstract

Retrospective Cohort Analysis. 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. 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 1month, 3months, 6months, and 1year after fusion. New cancer incidence following spinal tumor surgery was assessed until 5years postoperatively. 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 3months 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. 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.