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临床试验/NCT02815215
NCT02815215Unknown早期 1 期

A Retrospective Multicenter Analysis on Treatment of Congenital Idiopathic Clubfoot With Minimally Invasive Carroll's Technique

LiMing1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年6月1日最近更新:
适应症

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

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

发起方
LiMing
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

LiMing

Chief of Pediatric Orthopedics

Children's Hospital of Chongqing Medical University

研究点 (1)

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