A Retrospective Multicenter Analysis on Treatment of Congenital Idiopathic Clubfoot With Minimally Invasive Carroll's Technique
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Dimeglio classification system
研究概览
简要总结
Congenital clubfoot(CCF) is a kind of common congenital foot deformities in children. Though Ponseti method can cure most of the CCF patients, there are still part of patients can not get satisfactory recovery, especially those children classified as Dimeglio grade Ⅲ and Ⅳ. Carroll's technique is considered to be an ideal method of surgical treatment. But the postoperative scar is relatively large, and accordingly the postoperative complications is still common. Based on the clinical practice of the investigator's group, a modification of Carroll's technique, minimally invasive Carroll's technique, was applied. For the Dimeglio grade Ⅲ and Ⅳ CCF, the postoperative excellent and good rate was over 90%. Therefore, the investigator conducted a multicenter randomized controlled trial on treatment of congenital idiopathic clubfoot with minimally invasive Carroll's technique.
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
- 28 Days 至 4 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First diagnosed congenital idiopathic clubfoot cases classified as Dimeglio grade Ⅲ and Ⅳ
排除标准
- •Age≤28 days, and Age>4 years.
- •Accompanied by serious diseases of other organs.
- •Children with inherited metabolic disease and connective tissue disease.
- •Clubfoot caused by trauma, cerebral palsy, congenital multiple joint contracture, polio, spina bifida occulta, and clubfoot derived from spinal cord disease.
结局指标
主要结局
Dimeglio classification system
时间窗: 0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment)
evaluate the grade before and after treatment
次要结局
- Pirani scoring system(0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment))
研究者
LiMing
Chief of Pediatric Orthopedics
Children's Hospital of Chongqing Medical University
