思春期特発性側弯症に対する新規半剛性装具の評価

基本情報

NCT ID

NCT07040150

ステータス

実施中（募集終了）

試験のフェーズ

-

試験タイプ

観察

目標被験者数

60

治験依頼者名

Nippon Sigmax co., ltd.

概要

Introduction: 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. Materials and Methods: The investigators enrolled patients who met the following Scoliosis Research Society (SRS) 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 days using embedded temperature sensors. Correction rates were assessed at initiation and after 180 days or more.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)