Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in Cobb angle
研究概览
简要总结
Adolescent Idiopathic scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. The design is made relatively corsets empirically, hence the relative efficiency of this treatment. Our team has developed innovative methods for design, optimization and computer aided manufacturing-based numerical simulation models customized to each patient, and a system of evaluation and adjustment of corsets. In this project, the investigators will evaluate the effectiveness of this platform customized treatment and demonstrate its clinical application
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10 years or older
- •AIS diagnosis
- •Risser 0-2
- •Primary curve angles 20 degrees - 40 degrees
- •If female, either premenarchal or less than 18 months postmenarchal.
排除标准
- •Patients with a pre-existing cardiovascular condition
- •Patients with symptom of a neurological disorder
- •Patients with any other disorder of the musculoskeletal system affecting the lower limbs,
结局指标
主要结局
Change in Cobb angle
时间窗: Baseline, 6 months, 1 year
Radiographics will be gathered and analyzed to observe changes between time points. All radiographs will be taken with an low-dose biplane radiographic system (EOS) to allow 3D reconstructions.
次要结局
- Change in surface topography(Baseline, 6 months, 1 year)
- Change in Scoliosis Research Society questionnaire (SRS-22r) scores(Baseline, 6 months, 1 year)
研究者
Hubert Labelle, MD
Orthopedist, researcher
St. Justine's Hospital