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  • Does Recombinant Human Bone Morphogenetic Protein-2 (BMP) Use in Adult Spinal Deformity (ASD) Increase Complications and Are Complications Dose Related? A Prospective, Multicenter Study of 257 Consecu

    Final Number:

    S. Bess MD; B. Line BSME; O. Boachie-Adjei MD; R. Hart MD; V.Lafage PhD; F. Schwab MD; B. Akbarnia MD; C. Ames MD; D. Burton MD; R. Hostin MD; E. Klineberg MD; G. Mundis MD; C. Shaffrey MD, FACS; J. Smith MD PhD

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2012 Annual Meeting

    Introduction: As off-label BMP use in ASD surgery has increased, BMP associated complications and under-reporting of acute complications have come under scrutiny. Purpose: evaluate BMP associated complication rates following ASD surgery.

    Methods: Multicenter, prospective analysis of complication rates following ASD surgery for consecutive ASD patients receiving BMP (BMP) or no BMP (NOBMP). Inclusion criteria: age =18 years, ASD surgery (ASD=scoliosis =20 degrees, sagittal vertical axis (SVA) =5cm, pelvic tilt (PT) =25 degrees, or thoracic kyphosis (TK)> 60 degrees), complete demographic, radiographic, and operative data, and minimum 8 weeks follow up. Rates of major, minor, and complications requiring surgery evaluated. Correlations between total BMP dose, BMP dose/level and complications evaluated. Multivariate analysis performed.

    Results: 257 of 316 patients, mean follow up 20.3 months (range 2.2-38), met inclusion criteria. BMP (n=155; average PSF dose 2.4mg/level; range 0-12 mg/level; average interbody dose 2 mg/level; range 0-18 mg) and NO BMP (n= 102) had similar age, BMI, smoking history, prior spine surgery, maximal scoliosis, SVA, levels fused, and estimated blood loss (p>0.05). BMP had greater Charlson comorbidity index, operative time, osteotomies/patient, and anteroposterior surgery (p<0.05). Total complications per patient were greater for BMP vs. NOBMP (1.0 vs.0.5; p<0.05), however major complications, neurological and wound complications, superficial and deep infections, and complications requiring surgery were similar for BMP vs. NOBMP (p>0.05). Total posterior (PSF) BMP dose statistically correlated with total, major and neurological complications (p<0.05), however r values indicated small correlations (0.32, 0.14 and 0.14, respectively). PSF BMP dose per level did not correlate with major, wound or neurological complications, deep infections or return to OR (p<0.05).

    Conclusions: BMP use in ASD, at BMP dose/level reported, is not associated with wound, superficial or deep infections or return to OR. Further research is needed to evaluate long term complications and complications associated with higher dosing.

    Patient Care: This research improves patient care by providing surgeons and other healthcare providers with information regarding complications and the use of bone morphogenetic protein in spinal deformity surgery.

    Learning Objectives: By the conclusion of this presentation, participants should: (1) appreciate that bone morphogenetic protein (BMP) use in adult spinal deformity, at the doses reported in the present assessment, is not associated with increased rates of wound infections (superficial or deep) or return to the operating room, (2) appreciate that future research is still needed to further clarify complications associated with specific BMP dosing and to correlate BMP use and complications with clinical outcomes.


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