Effects of Bracing in Adolescents with Idiopathic Scoliosis
BACKGROUNDThe role of bracing in patients with adolescent idiopathic scoliosis who are at risk for curve progression and eventual surgery is controversial.
METHODSWe conducted a multicenter study that included patients with typical indications for bracing due to their age, skeletal immaturity, and degree of scoliosis. Both a randomized cohort and a preference cohort were enrolled. Of 242 patients included in the analysis, 116 were randomly assigned to bracing or observation, and 126 chose between bracing and observation. Patients in the bracing group were instructed to wear the brace at least 18 hours per day. The primary outcomes were curve progression to 50 degrees or more (treatment failure) and skeletal maturity without this degree of curve progression (treatment success).
RESULTSThe trial was stopped early owing to the efficacy of bracing. In an analysis that included both the randomized and preference cohorts, the rate of treatment success was 72% after bracing, as compared with 48% after observation (propensity-score–adjusted odds ratio for treatment success, 1.93; 95% confidence interval [CI], 1.08 to 3.46). In the intention-to-treat analysis, the rate of treatment success was 75% among patients randomly assigned to bracing, as compared with 42% among those randomly assigned to observation (odds ratio, 4.11; 95% CI, 1.85 to 9.16). There was a significant positive association between hours of brace wear and rate of treatment success (P<0.001).
Bracing significantly decreased the progression of high-risk curves to the threshold for surgery in patients with adolescent idiopathic scoliosis. The benefit increased with longer hours of brace wear. (Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and others; BRAIST ClinicalTrials.gov number, NCT00448448.)
The views expressed in this article are those of the authors and do not necessarily represent the official views of any of the funding institutions.
Supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (R21AR049587 and R01AR052113, to Dr. Weinstein), the Children’s Miracle Network (to Dr. Weinstein), the Canadian Institutes of Health Research (FRN-81050, to Dr. Wright), the Shriners Hospitals for Children (79125, to Dr. Dobbs), the University of Rochester, and the Children’s Mercy Hospitals and Clinics.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. No potential conflict of interest relevant to this article was reported. This article was published on September 19, 2013, at NEJM.org. We thank the many patients and families who participated in this trial and the research coordinators and staff at the participating institutions.
Source Information From the Department of Orthopedics and Rehabilitation, University of Iowa, Iowa City (S.L.W., L.A.D.); the Department of Orthopedic Surgery, Hospital for Sick Children, Toronto (J.G.W.); and the Department of Orthopedic Surgery, Washington University School of Medicine and St. Louis Shriners Hospital for Children, St. Louis (M.B.D.). Address reprint requests to Dr. Weinstein at the Department of Orthopedics and Rehabilitation, University of Iowa, 200 Hawkins Dr., Iowa City, IA 52242, or at email@example.com.
Stuart L. Weinstein, M.D., Lori A. Dolan, Ph.D., James G. Wright, M.D., M.P.H., and Matthew B. Dobbs, M.D. N Engl J Med 2013; 369:1512-1521October 17, 2013DOI: 10.1056/NEJMoa1307337