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.
METHODS
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.


BACKGROUND
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.


METHODS
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.


CONCLUSIONS
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.


METHODS
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.
Shay
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Bess
Breton G
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Virginie
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Lafage
Frank
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Schwab
Christopher I
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Shaffrey
Robert A
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Hart
Oheneba
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Boachie-Adjei
Behrooz A
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Akbarnia
Christopher P
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Ames
Douglas C
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Burton
Vedat
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Deverin
Kai-Ming G
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Fu
Munish
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Gupta
Richard
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Hostin
Khaled
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Kebaish
Eric
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Klineberg
Gregory
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Mundis
Michael
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O'Brien
Alexis
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Shelokov
Justin S
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Smith
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D055396:Bone Morphogenetic Protein 2 / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000139:chemically induced / Q000175:diagnosis / Q000453:epidemiology*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012600:Scoliosis / Q000453:epidemiology* / Q000601:surgery*; D013123:Spinal Fusion / Q000009:adverse effects*; D016212:Transforming Growth Factor beta / Q000008:administration & dosage* / Q000009:adverse effects*; D055815:Young Adult
D055396:Bone Morphogenetic Protein 2; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta; C499469:recombinant human bone morphogenetic protein-2