Casting vs Bracing for Idiopathic Early-Onset Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 71
- 试验地点
- 26
- 主要终点
- Curve Response
研究概览
简要总结
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis
详细描述
This study uses a multicenter, prospective hybrid research design, which will combine two methods of treatment assignment (randomized and parent preference) and an embedded internal pilot study for sample size re-estimation. Patients will be treated either with serial casts or a full-time brace and followed until curve resolution, failure or palliation (neither resolution nor failure after 2 years of treatment). Results of this study will provide clinicians and families with evidence to support informed treatment decisions.
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 (Outcomes Assessor)
盲法说明
Study outcome is determined from serial radiographs. Radiographic readers will be blinded to the treatment assigned or received.
入排标准
- 年龄范围
- 12 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Will enroll both patients with scoliosis and 1 of their parents/guardians
- •Inclusion Criteria:
- •Patient Inclusion
- •Diagnosis of idiopathic early-onset scoliosis
- •Child standing independently but not older than 3 years of age
- •20≤ Cobb angle ≤70° (largest structural curvature)
- •Rib-vertebral angle difference (RVAD) greater than 20 degrees or Rib Phase II
- •Parental consent to participate
- •Parent Inclusion
- •Parent or guardian of the minor subject
- •Consent to participate
- •Able to complete surveys
排除标准
- •Patient Exclusion
- •Previous operative or non-operative treatment for idiopathic early-onset scoliosis
- •Not independently walking by 18 months of age or other signs/symptoms indicative of developmental delay
研究组 & 干预措施
Casting
Subjects will be treated with serial casting
干预措施: Casting (Procedure)
Bracing
Subjects will be treated with full-time orthotics (braces)
干预措施: Bracing (Device)
结局指标
主要结局
Curve Response
时间窗: on or before 24 months of treatment
Resolution - curve improvement to \<15 degrees (as measured on 2 consecutive radiographs) Failure 1. Initial Cobb 20-50° (inclusive): curve progression of ≥20° resulting in a curve ≥50° 2. Initial Cobb \>50°: curve progression of ≥20° Palliation - 2 years of treatment without resolution or failure
次要结局
- Patient Health-related Quality of Life (HRQOL)(on or before 24 months of treatment)
研究者
Stuart L. Weinstein, MD
Professor
University of Iowa