Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 11
- 主要终点
- Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs
研究概览
简要总结
The goal of this multi-center, randomized, controlled trial is to evaluate the effectiveness of a 2 year versus 4 year bracing protocol in preventing isolated clubfoot recurrence within the first year post-treatment, and to evaluate factors associated with recurrence in isolated clubfoot.
详细描述
The study is based on the hypothesis that prolonged bracing will reduce clubfoot recurrence. In addition to bracing length, the study will determine if other factors in addition to duration of brace wear are associated with recurrence.
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
- None
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject < 1 year of age when treatment initiated at local site
- •Confirmed diagnosis of Isolated Clubfoot
- •At least one foot demonstrates fixation of the foot in equinus, forefoot adduction, cavus and hindfoot varus
- •Deformity was present at birth
排除标准
- •Previous foot abduction bracing
- •Previous surgical correction (excluding Tenotomy)
- •Dysmorphic features, additional anomalies (i.e. congenital heart disease, hypospadias, a genetic syndrome), or developmental delay
- •Neurologic cause for clubfoot (i.e. myelomeningocele or sacral agenesis)
结局指标
主要结局
Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs
时间窗: From end of bracing treatment until the earliest recurrence up to 1 year (allowing for per-protocol visit window of 1.2 years) after the assigned treatment (2- or 4-year bracing) is discontinued.
Kaplan-Meier recurrence-free survival probability for each limb affected by clubfoot up to 1 year after bracing is discontinued. For patients with bilateral clubfoot, each limb was assessed. Bilateral patients contribute data for both limbs and unilateral patients contribute data for the affected limb. Recurrence is defined as the development of any of the following deformities in isolation or in combination that require repeat cast application or surgical intervention: hindfoot varus, ankle equinus, midfoot adduction, midfoot cavus, or forefoot pronation. Clubfoot recurrence was determined by the local Principal Investigator.
次要结局
未报告次要终点