Brace treatment is effective in idiopathic scoliosis over 45°: An observational prospective cohort controlled study

Background context Recently, positive results in bracing patients with idiopathic scoliosis (IS) above 45° who refused surgery have been presented in a retrospective study. Obviously, this can give only an efficacy (EA) analysis, as there is neither a control group, nor it is possible to know failures because of dropouts. Purpose To present the prospective results of bracing patients affected by IS above 45° and still growing. Study design Prospective study including all IS patients with 45° or more, Risser stage 0 to 4, who had their first evaluation in our institute, an outpatient clinic specialized in scoliosis evaluation and conservative treatment, from March 1, 2003 to December 21, 2010 and utterly denied any surgical intervention. Patient sample Of 59 patients, we excluded 2 patients still in treatment and 57 (11 males) patients were included. At the beginning of the study, they were 15 years 3±22 months of age, had 52.5° Cobb (range, 45°-93°), and Risser 2 (0-4). Thirty-nine accepted a full-time brace treatment (BG) to try avoiding surgery, 18 refused any treatment and served as controls (CG). Outcome measures Physiological measures: radiographic and clinical data. Methods Treatment: A year of full-time Sforzesco brace (23 hours/day) or Risser cast (8-12 months) and gradual weaning after Risser 3; all patients performed exercises; and International Society on Scoliosis Orthopaedic and Rehabilitation Treatment management criteria were respected. Analyses: EA in patients who completed treatment/observation (34 in BG and 10 in CG) and intent-to-treat (ITT) with worst case analysis in the whole population. Relative risk (RR) and 95% confidence interval (CI) have been computed. Results Efficacy: failures were 23.5% in BG and 100% in CG. Intent-to-treat: failures were 20.5% in BG and 55.6% in CG. Relative risks of failure in CG were 4.3 (95% CI, 3.6-4.9) in EA and 2.7 (95% CI, 2.0-3.5) in ITT (p