The outcome of modified version of the Cheneau brace in Adolescent Idiopathic Scoliosis (AIS) based on SRS and SOSORT criteria: a retrospective study.

BACKGROUND: Bracing therapy for patients with adolescent idiopathic scoliosis (AIS) continues to be a controversial issue. As a consequence, to achieve an adequate level of evidence, there is a strong need for specific studies conducted according to standard outcome and management criteria. AIM: To assess the outcomes of a modified version of the Cheneau brace, ("Cheneau-P") in patients with AIS, based on SRS and SOSORT criteria. DESIGN: Retrospective study. SETTING: Scoliosis Unit of a Clinical Center. POPULATION: Sixty-seven patients, 56 females and 11 males. METHODS: Inclusion criteria were: diagnosis of AIS, age >= 10 years, Risser Score 0-2, Cobb degrees 20-40, no previous treatment, beginning of brace treatment within 1 year after menarche and minimum 2-year follow-up. According to SRS criteria, bracing outcomes were classified, as follows: "improved" (reduction of the curve >= 6 degrees), "unchanged" (5 degrees curve progression or reduction), "worsened" (>= 6 degrees curve progression), and "over 45 degrees" (curve exceeding 45 degrees or undergone surgery during the follow-up). The outcomes "improved" and "unchanged" were considered as successful outcomes. Groups and related subgroups were created according to curve type (thoracic, thoraco-lumbar, lumbar and double major) and magnitude (20 degrees-30 degrees; 30 degrees-40 degrees) and to skeletal age (Risser score 0, 1, 2). A separate analysis was also performed on the 37 patients, 30 females and 7 males, who completely fulfilled the SRS eligibility criteria, showing spinal curves between 25 and 40 Cobb degrees. RESULTS: In the whole group SRS outcome after bracing treatment was successful in 93% and in 81% of patients, at per protocol (PP) and intention to treat (ITT) analysis, respectively, the latter also including drop-outs as worst outcomes. Cobb angles significantly decreased in all subgroups except in patients showing double major curves, lower curve magnitude (20-30 degrees) and Risser score 2. Rib humps and balance rate also significantly improved in the whole sample (12.78 +/- 4.54 at TO vs. 6.83 +/- 4.33 at T1 P<0.001; 60% at TO vs. 94% at T1 P<0.001, respectively) In the subgroup that completely fulfilled the SRS eligibility criteria, the outcome was successful in 92% and 83% of patients, at PP and ITT analysis, respectively, the latter also including, even in this case, drop-outs as worst outcomes. CONCLUSIONS: This study shows that in patients with AIS the treatment with the "Cheneau-P" brace is associated with a remarkably high rate of successful outcomes, both in the whole sample and in the subgroup of patients completely fulfilling the SRS criteria.