Does recombinant human bone morphogenetic protein-2 use in adult spinal deformity increase complications and are complications associated with location of rhBMP-2 use? A prospective, multicenter study of 279 consecutive patients.
STUDY DESIGN: Multicenter, prospective analysis of consecutive patients with adult spinal deformity (ASD). OBJECTIVE: Evaluate complications associated with recombinant human bone morphogenetic protein-2 (rhBMP-2) use in ASD. SUMMARY OF BACKGROUND DATA: Off-label rhBMP-2 use is common; however, underreporting of rhBMP-2 associated complications has been recently scrutinized. METHODS: Patients with ASD consecutively enrolled into a prospective, multicenter database were evaluated for type and timing of acute perioperative complications. INCLUSION CRITERIA: age 18 years and older, ASD, spinal arthrodesis of more than 4 levels, and 3 or more months of follow-up. Patients were divided into those receiving rhBMP-2 (BMP) or no rhBMP-2 (NOBMP). BMP divided into location of use: posterior (PBMP), interbody (IBMP), and interbody + posterior spine (I + PBMP). Correlations between acute perioperative complications and rhBMP-2 use including total dose, dose/level, and location of use were evaluated. RESULTS: A total of 279 patients (mean age: 57 yr; mean spinal levels fused: 12.0; and mean follow-up: 28.8 mo) met inclusion criteria. BMP (n = 172; average posterior dose = 2.5 mg/level, average interbody dose = 5 mg/level) had similar age, smoking history, previous spine surgery, total spinal levels fused, estimated blood loss, and duration of hospital stay as NOBMP (n = 107; P > 0.05). BMP had greater Charlson Comorbidity Index (1.9 vs. 1.2), greater scoliosis (43° vs. 38°), longer operative time (488.2 vs. 414.6 min), more osteotomies per patient (4.0 vs. 1.6), and greater percentage of anteroposterior fusion (APSF; 20.9% vs. 8.4%) than NOBMP, respectively (P < 0.05). BMP had more total complications per patient (1.4 vs. 0.6) and more minor complications per patient (0.9 vs. 0.2) than NOBMP, respectively (P < 0.05). NOBMP had more complications requiring surgery per patient than BMP (0.3 vs. 0.2; P < 0.05). Major, neurological, wound, and infectious complications were similar for NOBMP, BMP, PBMP, IBMP, and I + PBMP (P > 0.05). Multivariate analysis demonstrated small to nonexistent correlations between rhBMP-2 use and complications. CONCLUSION: RhBMP-2 use and location of rhBMP-2 use in ASD surgery, at reported doses, do not increase acute major, neurological, or wound complications. Research is needed for higher rhBMP-2 dosing and long-term follow-up. LEVEL OF EVIDENCE: 2.
Bess, S; Line, BG; Lafage, V; Schwab, F; Shaffrey, CI; Hart, RA; Boachie-Adjei, O; Akbarnia, BA; Ames, CP; Burton, DC; Deverin, V; Fu, K-MG; Gupta, M; Hostin, R; Kebaish, K; Klineberg, E; Mundis, G; O'Brien, M; Shelokov, A; Smith, JS; International Spine Study Group ISSG,
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