Development and short-term evaluation of a novel semi-rigid brace for adolescent idiopathic scoliosis: Results from a multicenter prospective observational study of the first 60 patients.

Abstract

Spinal bracing remains the gold standard for conservative management of adolescent idiopathic scoliosis (AIS). However, poor adherence often limits treatment efficacy. The development of a brace that enhances compliance while maintaining sufficient corrective force is crucial. This study aimed to develop and evaluate the effectiveness of a novel semi-rigid brace for AIS based on wearing time and correction rate. Multicenter prospective observational study. We enrolled patients who met the following Scoliosis Research Society criteria for brace treatment: (1) confirmed AIS diagnosis, (2) Risser sign ≤2, (3) Cobb angle between 25° and 40°, (4) age ≥10 years, and (5) single-curve pattern. Wearing time was objectively measured over 180 d using embedded temperature sensors. Correction rates were assessed at initiation and after 12 months or more. A total of 60 patients with AIS were included. Among them, 24 had thoracic curves, and 36 had thoracolumbar/lumbar curves. The mean daily wearing time was 16.3 h for thoracic curves and 18.2 h for thoracolumbar/lumbar curves. The median initial correction rate was 32% for thoracic curves and 45% for thoracolumbar/lumbar curves. After 12 months or more, the median correction rate was 20% and 48%, respectively. The dropout rate was 5%, and no severe skin complications were observed. The novel semi-rigid brace demonstrated high compliance and effective curve correction over 12 months. These findings support its potential as a comfortable and effective conservative treatment option for patients with AIS.