Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 58
- 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. Our team has developed an innovative conception method for brace design by simulating the growth modulation using numerical models. Those models are customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform customized treatment and validate 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 a 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 - 2 years
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
- Treatment failure rate(Baseline, 2 years)
- Immediate in-brace Cobb angle(5 minutes after brace fitting)
- Quality of Life (QoL)(Baseline, 2 years)
研究者
Hubert Labelle, MD
Orthopedist, researcher
St. Justine's Hospital