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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Wearing time
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed AIS
- •Risser sign ≤ 2
- •Cobb angle between 25° and 40°
- •age ≥ 10 years
- •single-curve pattern (thoracic or thoracolumbar/ lumbar)
- •premenarchial or less than one year post-menarche.
排除标准
- •Patients who do not meet the SRS criteria for orthosis suitability
- •Patients with a history of spinal surgery
结局指标
主要结局
Wearing time
时间窗: 180 days from registration
次要结局
- Initial correction rate(Immediately after registration)
- Correction rate after 180 days or more(180 days or more from registration)
- Treatment success rate(2 years or more from registration)