Twenty-Year Retrospective Analysis of Bone Morphogenetic Protein (BMP) Use in Anterior Cervical Fusion

STUDY DESIGN: Retrospective, nonrandomized. OBJECTIVE: The objective of this study is to assess the incidence of severe swallowing and airway complications in patients who underwent anterior cervical discectomy and fusion (ACDF) with low-dose bone morphogenetic protein (BMP) by a single surgeon. SUMMARY OF BACKGROUND DATA: The FDA released a black box warning against the use of BMP in ACDF surgeries in 2008, but few studies have reported the incidence of complications cited in the warning. Further, few studies have longitudinally tracked the use of low-dose BMP in the cervical spine and reported complication rates. This study aims to fill a gap in the literature by providing a 20-year longitudinal review of the use of low-dose BMP by a single surgeon. METHODS: The retrospective analysis assessed patients who underwent ACDF surgeries from 2003 to 2023 by a single surgeon. Patient demographics and surgical characteristics were identified. Complications, as defined by the FDA Black Box Warning, were prospectively recorded. Statistical analysis included binary logistic regressions to predict complications. RESULTS: One thousand ten patients were included in this study. 2.2% of the patients developed a Black Box Complication. In response to these complications, 1.5% of patients received intravenous steroids, 0.2% of patients were reintubated, 0.2% of patients underwent second surgeries to drain the surgical site, and 2.1% of patients were readmitted for swallowing or airway complications. No patients required a tracheostomy. CONCLUSIONS: The complication rates of the current study are comparable to the published rates of ACDF procedures without BMP. Given the current study and the growing body of evidence supporting the safety and efficacy of low-dose BMP, categorical cautions against the use of BMP in the cervical spine should be reconsidered. LEVEL OF EVIDENCE: Level III.