106. Usage trends and safety profile of recombinant human bone morphogenetic protein-2 for spinal column tumor surgery: a national matched analysis

Abstract

<h3>BACKGROUND CONTEXT</h3> Achieving arthrodesis after spinal tumor surgery remains a significant challenge. Patients in this vulnerable cohort commonly experience poor bone quality, malnutrition and concurrent use of chemotherapy or radiotherapy—all of which interfere with proper bone formation and healing. To augment fusion efforts, recombinant human bone morphogenetic protein-2 (rhBMP-2) emerged as a powerful osteogenic factor after its FDA approval in 2002 but its use has remained a persistent concern. Although most recent evidence does not seem to suggest significantly increased rates of complications or carcinogenicity due to rhBMP-2 use, these findings remain poorly defined in the spinal oncology subcohort. <h3>PURPOSE</h3> To investigate national rates of rhBMP-2 utilization in spinal tumor surgery and examine its association with postoperative complications, revisions, and carcinogenicity. <h3>STUDY DESIGN/SETTING</h3> Retrospective national database analysis. <h3>PATIENT SAMPLE</h3> All patients diagnosed with primary or metastatic spinal tumors who underwent subsequent surgical intervention involving a spinal fusion recorded in Medicare, Medicaid, and commercial administrate claims databases in PearlDiver from 2005-2020. <h3>OUTCOME MEASURES</h3> Utilization rates; postoperative rates of complications, revisions, and failures; survivorship. <h3>METHODS</h3> Patients were organized into two cohorts according to rhBMP-2 usage and 1:1 matched based on age, gender, and Charlson Comorbidity Index. rhBMP-2 utilization trends were compared via a Pearson correlation across calendar years. Postoperative complications and revisions were examined at 1 month, 3 months, 6 months, and 1 year after spinal fusion. New cancer incidence following spinal tumor surgery was assessed until 5 years postoperatively. Post hoc comparisons were characterized using chi-squared analysis, and threshold for significance was established at P < 0.05. <h3>RESULTS</h3> 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 = 0.859, P < 0.001), with the most recent annual utilization rate at 1.1%. The final matched cohorts each comprised 894 patients. At least 6 months after surgery, significantly increased incidences of surgical site (7.3% vs 1.6%, P = 0.05) and systemic infections (13.8% vs 4.1%, P = 0.01) were observed in patients who underwent fusion with rhBMP-2. Across all time points, no significant differences were observed between the groups in survival, implant removal, or revision rates. In addition, incidence of new cancer diagnoses after fusion surgery was comparable between the two groups. <h3>CONCLUSIONS</h3> rhBMP-2 has been widely used off-label to promote arthrodesis; however. its role in spinal fusion procedures involving spinal tumors remains controversial. This analysis demonstrated significantly declining national utilization rates, and while rhBMP-2 usage was not associated with new cancer incidence postoperatively, its impact on local and metastatic progression remains unknown and requires further investigation. Compared with nonusers, spinal tumor cases utilizing rhBMP-2 sustained greater rates of surgical site and systemic infections. Furthermore, rhBMP-2 usage did not significantly reduce the risk of mortality, implant failure, or reoperation–suggesting it may not be essential to fulfilling the needs of this specific patient population. <h3>FDA DEVICE/DRUG STATUS</h3> BMP-2: not approved for this indication.