Among adolescents with idiopathic scoliosis, a rigid thoracolumbosacral orthosis significantly decreased the progression of high-risk curves to the threshold for surgery. Longer hours of orthosis wear were associated with greater benefit, according to recent study results published in the New England Journal of Medicine.
Researchers included patients aged 10 to 15 years with typical indications for orthotic treatment due to their age, skeletal immaturity and degree of scoliosis in a multicenter study, enrolling both a randomized cohort and a treatment preference cohort. Overall, 146 patients received orthotic treatment, whereas 96 patients received no treatment. Researchers instructed the patients in the orthosis group to wear the brace at least 18 hours per day.
Primary outcomes included curve progression to 50° or more (treatment failure) and skeletal maturity without this degree of curve progression (treatment success).
Study results showed a 72% rate of treatment success after treatment in an analysis that included both the randomized and preference cohorts, compared with 48% treatment success after observation only. In the intention-to-treat analysis, the rate of treatment success was 75% among patients randomly assigned to orthotic wear and 42% among patients randomly assigned to observation.
Researchers also found a significant positive association between hours of orthosis wear and rate of treatment success. Patients who wore the orthosis at least 12.9 hours per day had treatment success rates between 90% and 93%, compared with 41% in patients who wore the orthosis for a mean 0 to 6 hours per day.
The trial was stopped early due to the efficacy of orthotic treatment.
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Disclosure: The researchers reported no relevant financial disclosures.