Comparison of Two Different Cast Materials for the Treatment of Congenital Idiopathic Clubfoot Using the Ponseti Method: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- number of casts required to correct the clubfoot deformities
研究概览
简要总结
The purpose of this study was to determine the influence of cast material on correction of congenital idiopathic clubfeet using the Ponseti method.
详细描述
Congenital idiopathic clubfoot is the most common congenital deformity in children. It can be a major cause of disability for children, as well as an emotional stress for parents. The Ponseti method of clubfoot correction, consisting of serial manipulations and casting, is now the gold standard of treatment. It has traditionally been described using plaster of Paris (POP) above-knee casts; however, recently semi-rigid fiberglass softcast (SRF, 3M Scotchcast) has grown in popularity. There are currently no randomized controlled trials to prove its efficacy with respect to POP.
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
- 1 Week 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •congenital idiopathic clubfoot
排除标准
- •positional equinovarus
- •teratologic etiologies of clubfoot
- •treatment started at another center
- •refuse randomization
- •do not understand English
结局指标
主要结局
number of casts required to correct the clubfoot deformities
时间窗: time required for the foot to be ready for a percutaneous tendo-achilles tenotomy (if necessary), or when dorsiflexion of the ankle greater than or equal to 15 degrees (Pirani=0) was achieved
次要结局
- need for percutaneous tendo-achilles tenotomy
- total time in casts (weeks)
- ease of cast removal
- time of cast removal(number of minutes required for each cast removal)
- method(s) of cast removal
- other concerns about the casting material (e.g. appearance, weight, cleaning, water resistance), and complications relating to the casting material.