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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

doi: 10.1097/BRS.0000000000000104

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

Multicenter, prospective, analysis of 279 consecutive patients with adult spinal deformity demonstrated that use of recombinant human bone morphogenetic protein-2 (rhBMP-2) and location of rhBMP-2 use (mean posterior dose = 2.5 mg/level, mean interbody dose = 5 mg/level) did not increase acute major, neurological, or wound complications, or superficial or deep wound infections compared with patients not receiving rhBMP-2.

*Rocky Mountain Hospital for Children, Denver, CO

Rocky Mountain Scoliosis & Spine, Denver, CO

Department of Orthopedic Surgery, New York University School of Medicine, New York, NY

§Department of Neurosurgery, University of Virginia School of Medicine, Charlottesville, VA

Department of Orthopedic Surgery, University of Oregon Health Sciences Center; Portland, OR

Department of Orthopedic Surgery, Hospital for Special Surgery, New York, NY

**San Diego Center for Spinal Disorders, La Jolla, CA

††University of California San Francisco, San Francisco, CA

‡‡Department of Orthopedic Surgery, University of Kansas School of Medicine, Wichita, KS

§§Department of Orthopedic Surgery, University of California San Francisco, San Francisco, CA

¶¶Department of Neurosurgery, Cornell University School of Medicine, New York, NY

‖‖Department of Orthopedic Surgery, University of California Davis, Davis, CA

***Baylor Scoliosis Center, Plano, TX; and

†††Department of Orthopedic Surgery, Johns Hopkins University School of Medicine, Baltimore, MD

[LATIN CROSS]Deceased.

Address correspondence and reprint requests to Shay Bess, MD, Rocky Mountain Scoliosis & Spine, Presbyterian/St. Luke's Medical Center, and Rocky Mountain Hospital for Children, 2055 High St, Ste 130 Denver, CO 80205; E-mail:

Acknowledgment date: June 4, 2013. Revision date: October 1, 2013. Acceptance date: October 14, 2013.

The device(s)/drug(s) that is/are the subject of this manuscript is/are not FDA approved for this indication and is/are not commercially available in the United States.

DePuy Synthes Spine grant funds were received to support this work.

Relevant financial activities outside the submitted work: board membership, consultancy, grants, payment for lecture, royalties, payment for development of educational presentations, payment for lecture, stocks, patents, expert testimony, travel/accommodations/meeting expenses.

© 2014 by Lippincott Williams & Wilkins