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Randomized Controlled Trial
. 2013 Oct 17;369(16):1512-21.
doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.

Effects of Bracing in Adolescents With Idiopathic Scoliosis

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Free PMC article
Randomized Controlled Trial

Effects of Bracing in Adolescents With Idiopathic Scoliosis

Stuart L Weinstein et al. N Engl J Med. .
Free PMC article

Abstract

Background: The role of bracing in patients with adolescent idiopathic scoliosis who are at risk for curve progression and eventual surgery is controversial.

Methods: We 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).

Results: The 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).

Conclusions: 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.).

Figures

Figure 1
Figure 1. Study Enrollment and Treatment of the Patients.
Between March 2007 and February 2011, a total of 1086 patients underwent screening. Of the 242 patients included in the primary analysis, 116 patients underwent randomization and were included in the intention-to-treat population. A total of 126 patients declined randomization and chose their preferred treatment. Patients were permitted to change treatment groups on request.
Figure 2
Figure 2. Rate of Treatment Success According to Average Hours of Daily Brace Wear.
During the first 6 months, patients wore the brace for a mean (±SD) of 12.1±6.6 hours per day (range, 0 to 23.0). Duration of brace wear was positively associated with the rate of success (P<0.001 by the chi-square test). The lowest quartile of wear (mean hours per day, 0 to 6.0) was associated with a success rate of 42%, whereas brace wear for an average of at least 12.9 hours per day was associated with success rates of 90 to 93%. I bars indicate 95% confidence intervals.

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