Skip Navigation LinksHome > February 01, 2014 - Volume 39 - Issue 3 > Does Recombinant Human Bone Morphogenetic Protein-2 Use in A...
Spine:
doi: 10.1097/BRS.0000000000000104
Deformity

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

Bess, Shay MD*; Line, Breton G. BSME; Lafage, Virginie PhD; Schwab, Frank MD; Shaffrey, Christopher I. MD§; Hart, Robert A. MD; Boachie-Adjei, Oheneba MD; Akbarnia, Behrooz A. MD**; Ames, Christopher P. MD††; Burton, Douglas C. MD‡‡; Deverin, Vedat MD§§; Fu, Kai-Ming G. MD¶¶; Gupta, Munish MD‖‖; Hostin, Richard MD***; Kebaish, Khaled MD†††; Klineberg, Eric MD‖‖; Mundis, Gregory MD**; O'Brien, Michael MD***; Shelokov, Alexis MD[LATIN CROSS]; Smith, Justin S. MD, PhD§; International Spine Study Group ISSG

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Abstract

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

© 2014 by Lippincott Williams & Wilkins

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