跳至主要内容
临床试验/CTRI/2019/02/017604
CTRI/2019/02/017604尚未招募4 期

Management of Clubfoot by Joshis External Stabilizing System.A comparison between Spring distractors and Manual distractors.

AIIMS RAIPUR1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年2月14日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
Good to Excellent reults as per international clubfoot group scores

研究概览

简要总结

Clubfoot is one of the oldest and commonest deformities affecting children. Severe clubfoot including neglected,recurrent and resistant forms cannot be managed by conservative methods and need surgical interventions. Surgery for Clubfoot has its own disadvantages. It is invasive and leads to scarring. Foot becomes rigid with soft tissue surgery and bony operations can make the foot even more smaller. To avoid it, a simple alternative is to use JESS and distractor components based on principle of controlled differential fractional distraction histogenesis. This is a percutaneous technique with minimal scarring allowing gradual distraction of soft tissues and align all the joints of foot so as to bring corrections of all aspects of deformity simultaneously. In this study, JESS fixator which is indigenous , less cumbersome , non bulky , economical and easy to apply. Latest addition in JESS assembly is spring distractor which utilise restoring force of the compressed spring to get desired distraction instead of daily manual distraction. Both manual and spring distractors for the correction of Clubfoot are acceptable methods. We are doing this study to find out which distraction sytem gives better and early correction and also is patient and user friendly.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
1.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Neglected, resistant, syndromic clubfoot.
  • Not responding to serial cast manipulation.

排除标准

  • Patients unfit for surgery.
  • Patients refusing surgery.
  • Patients with multiple Congenital limb abnormalities.

结局指标

主要结局

Good to Excellent reults as per international clubfoot group scores

时间窗: Follow up for 6 month

次要结局

  • Technical problem and complications arising during JESS usage(Follow up for 6 month)

研究者

发起方
AIIMS RAIPUR
申办方类型
Research institution

研究点 (1)

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