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Scientific Articles   |    
Factors Associated with Use of Bone Morphogenetic Protein During Pediatric Spinal Fusion SurgeryAn Analysis of 4817 Patients
Amit Jain, MD1; Khaled M. Kebaish, MD1; Paul D. Sponseller, MD1
1 c/o Elaine P. Henze, BJ, ELS, Medical Editor and Director, Editorial Services, Department of Orthopaedic Surgery, The Johns Hopkins University/Johns Hopkins Bayview Medical Center, 4940 Eastern Avenue, #A665, Baltimore, MD 21224. E-mail address for E.P. Henze: ehenze1@jhmi.edu
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Investigation performed at the Department of Orthopaedic Surgery, The Johns Hopkins University, Baltimore, Maryland

A commentary by Geoffrey F. Haft, MD, is linked to the online version of this article at jbjs.org.



Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Copyright © 2013 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2013 Jul 17;95(14):1265-1270. doi: 10.2106/JBJS.L.01118
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Abstract

Background: 

Our goal was to investigate whether the use of recombinant human bone morphogenetic protein (rhBMP, or BMP) during pediatric spinal fusion surgery has been increasing and how patient, surgical, and hospital characteristics influence BMP use.

Methods: 

Using the Nationwide Inpatient Sample database, we identified 4817 children eighteen years old or younger who had undergone spinal fusion surgery with the use of BMP from 2003 through 2009. A multivariate logistic regression model, the Z-test of proportions, and simple linear regression were used for statistical analysis (significance, p < 0.05).

Results: 

There was a 3.4-fold increase in BMP use, from 2.7% in 2003 to 9.3% in 2009—an average 16% per year increase (p < 0.01). For each additional year of age, BMP use increased 1.09-fold (odds ratio [OR]: 1.05 to 1.13, p < 0.01). Compared with BMP use for adolescent idiopathic scoliosis, the adjusted odds of BMP use were increased 1.3-fold for congenital scoliosis (OR: 1.02 to 1.76, p = 0.04), 2.8-fold for thoracolumbar fractures (OR: 2.1 to 3.8, p < 0.01), and 5.0-fold for spondylolisthesis (OR: 3.9 to 6.3, p < 0.01). Patients with private insurance were 1.5-fold more likely to receive BMP (OR: 1.2 to 1.9, p < 0.01). Patients in whom autograft bone was used intraoperatively were 0.63-fold less likely to receive BMP (OR: 0.52 to 0.77, p < 0.01). The rate of BMP use was 0.38-fold lower in teaching hospitals (OR: 0.31 to 0.48, p < 0.01) and 1.7-fold higher in hospitals with a large bed capacity (OR: 1.3 to 2.2, p < 0.01). Compared with hospitals located in the Northeast, those in the West had a 1.7-fold increase (OR: 1.3 to 2.4, p < 0.01) and those in the South had a 2.0-fold increase (OR: 1.5 to 2.7, p < 0.01) in the odds of BMP use.

Conclusions: 

Use of BMP during pediatric spinal fusion has increased significantly. Patient factors (age, diagnosis, and insurance), surgical factors (autograft use), and hospital factors (teaching status, bed capacity, and location) influenced the variation in BMP use.

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    References

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    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Paul D. Kiely, John O.Quinn, Matthew E. Cunningham
    Posted on October 10, 2013
    BMP is not routinely used in Pediatric Spine Surgery
    Scoliosis Spine Service, Hospital for Special Surgery, New York, NY 10021

    We congratulate Jain et al. on their study, but feel that the usage of BMP during pediatric spine surgery needs further clarification. The authors found a significant increase in the use of BMP in children during spinal fusion surgery, and determined that BMP use increased to >9% in 2009(1). This finding was consistent with the 9.2% rate that Dodwell et al.’s reported in their 2012 letter to the Journal of the American Medical Association (JAMA) (1).

    The literature regarding the use of BMP in pediatric spine surgery is very limited. These 2 studies have contributed to our knowledge on this controversial biologic agent. However, we believe they create a misconception about the off label use of rhBMP-2 usage in pediatric spinal arthrodesis. The incidence of BMP use in our institution is 1.5%, and reflects more accurately, we believe, the more judicious use of BMP by US Pediatric orthopaedic surgeons. Dodwell et al. found that 66.2% of BMP usage occurred in the Midwest and Southern regions of the USA, and we feel that these institutions are skewing the results of BMP use in pediatric spine surgery (1).

    Recently, two Yale University Open Data Access (YODA) reviews have been published highlighting the outcomes and adverse events of rhBMP-2 use in adult spine (2,3). Carragee et al. have previously concluded that that the risk of adverse events with rhBMP-2 was 10 to 50 times the original estimates reported in industry-sponsored peer reviewed publications (4). Unfortunately, the equivalent data regarding the safety and efficacy of BMP in pediatrics is not available, and further studies are required to determine the types, doses and long-term outcomes of BMP in children.

    In summary, as our own institutions’ results demonstrate, BMP is not routinely used in pediatric spine surgery, and further studies are warranted to clarify the indications, use, outcomes and complications of BMP in US children.

    REFERENCES
    1. Dodwell E, Snyder B, Wright J. Off-label use of bone morphogenetic proteins in pediatric spinal arthrodesis. JAMA 2012 Oct 10;308(14):1429-32.
    2. Krumholz HM, Ross JS, Gross CP, Emanuel EJ, Hodshon B, Ritchie JD, et al. A historic moment for open science: the Yale University Open Data Access project and Medtronic. Ann Intern Med 2013 Jun 18;158(12):910-1.
    3. Bono CM, Wetzel FT, North American Spine Society Executive Committee, endorsed by the North American Spine Society Section on Biologics. Black, white, or gray: how different (or similar) are YODA and the The Spine Journal reviews of BMP-2? Spine J 2013 Sep;13(9):1001-5.
    4. Carragee EJ, Hurwitz EL, Weiner BK. A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. Spine J 2011 Jun;11(6):471-91.

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