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临床试验/NCT02815306
NCT02815306已完成不适用

Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot in Newborns and Infants

Children's Hospital of Chongqing Medical University0 个研究点目标入组 88 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
主要终点
hindfoot

研究概览

简要总结

Congenital idiopathic clubfoot (CC) is the fifth most common congenital malformation in children. The Ponseti method is an effective protocol for treatment of congenital idiopathic clubfoot. Plaster is essential for the Ponseti treatment. This paper describes a new brace that can be used for the treatment of clubfoot in newborns and infants instead of plaster.

详细描述

Methods In the orthopedic department of our hospital, 38 infants and newborns, (57 feet) ,all the patients were under the age of 3 months with congenital clubfoot underwent polyaxial braces between Jan, 2011 to Oct ,2013. Polyaxial brace was used for the deformity correction. Then, during the following 1-3 years, the Dennis braces were used during the night in case of recurrence. Prospective follow-up for a mean duration of 25 months (range, 15-36months) was carried out. The efficacy of the treatment was assessed by Pirani's scoring system before and after treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Day 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 0-6 months infants parents would like to cooperate with the doctors.

排除标准

  • over 6 months.

结局指标

主要结局

hindfoot

时间窗: 1 month

severity of the posterior crease, emptiness of the heel and rigidity of the equinus

midfoot

时间窗: 1 month

curvature of the lateral border of the foot, severity of the medial crease and position of the lateral part of the head of the talus

次要结局

未报告次要终点

研究者

发起方
Children's Hospital of Chongqing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guoxin Nan

Chief of the orthopeadic deapartment

Children's Hospital of Chongqing Medical University

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