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Orthotic treatment is successful in adolescent idiopathic scoliosis
Researchers found that bracing can decrease progression of curves in high-risk patients with adolescent idiopathic scoliosis.
CHICAGO — Bracing significantly decreased progression of curves in high-risk patients with adolescent idiopathic scoliosis to the threshold for surgery, according to a recent presentation.
Lori Dolan, PhD, described results from the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST).
The goal of BrAIST was to produce credible evidence about bracing with rigid thoracolumbosacral orthosis (TLSO). BrAIST used research design elements which were lacking in previous literature, which have shown mixed results, she said.
The study also sought to determine the relationship between dose and curve response, and develop a predictive model for curve progression based on patient characteristics at initial presentation and after bracing.
The BrAIST study
The study was conducted in 25 institutions across the United States and Canada. Enrollment began in March 2007. Out of 1,086 eligible patients, 383 consented to participate in the study.
Lori Dolan
The multicenter, partially randomized study included high-risk patients between the ages of 10 years and 15 years, who were Risser 0, 1, 2, with a Cobb angle of 20° to 40° and apex at or caudal to T7, who received no previous orthopedic treatment.
Patients in the observation group received no specific treatment. Patients in the bracing group received a rigid TLSO prescribed to be worn for a minimum of 18 hours per day. Patients in the treated group received an in-orthosis radiograph 4 weeks to 6 weeks after delivery and an orthotist evaluation at least every 6 months. Participating centers prescribed the type of brace used in their normal clinical practice. Wear time was determined by means of a temperature logger embedded in the brace and programmed to log the date, time, and temperature every 15 minutes. A temperature of 28° C (82.4° F) or higher indicated that the brace was being worn. Patients who received a brace were considered to be treated, regardless of their level of compliance with prescribed brace wear. On average, patients in the treatment group wore the orthosis 12 hours per day.
Treatment success was defined as reaching skeletal maturity (Risser 4 and Risser 5 for boys, and a Sanders skeletal maturity stage of 7) with a Cobb angle of less than 50°.
The trial was stopped early due to treatment success. Two analyses were done. The randomized analysis yielded an odds ratio of 4.11, demonstrating the superiority of bracing in 116 patients, according to Dolan. The success rate in the bracing group was 74.5% and it was 41.5% in the observation group.
The primary analysis (combination of the randomized and preference groups) also demonstrated the effectiveness of bracing, Dolan noted.
Time in brace led to success
The trial results were published in the New England Journal of Medicine.
The authors summarized the findings as such: “In adolescents with idiopathic scoliosis who were considered to be at high risk for curve progression that would eventually warrant surgery, bracing was associated with a significantly greater likelihood of reaching skeletal maturity with a curve of less than 50°, as compared with observation alone. A significant benefit of bracing was observed in both the randomized and the as-treated populations. We also found a significant association between the average hours of daily brace wear and the likelihood of a successful outcome.”
Dolan, who is from the Department of Orthopedics and Rehabilitation at the University of Iowa, Iowa City, said at the meeting that as the average hours of orthosis wear increased, so did the success rate.
“In a preliminary analysis of the first 6 months of brace wear we found a strong correlation between average hours per day in the brace and success rate. The kids who were wearing their braces zero to 6 hours a day had the same rate of success as those in the observation group,” Dolan said. “The rate of success in the group averaging 13 hours to 18 hours per day (90%) was basically equivalent to those who wore the brace 18 plus hours per day.”
Also, of note, is the fact that 42% of the group randomized to observation had successful outcomes, indicating that the current indications for bracing may be too broad, resulting in unnecessary treatment, Dolan noted. – by Carey Cowles and Robert Linnehan
References:
Weinstein SL. N Engl J Med. 2013. doi:10.1056/NEJMoa1307337.
For more information:
Disclosure: The BrAIST study received support from the National Institutes of Health, The Shriner’s Hospital for Children, the Canadian Institutes of Health Research, Children’s Mercy Hospital (Kansas City, Mo.) and the University of Rochester, in Rochester, N.Y. Dolan has no relevant financial disclosures.