跳至主要内容
临床试验/NCT07125794
NCT07125794招募中不适用

The Original Denis Brawn Brace Versus Its Modification for Management of Relapsed Idiopathic Clubfoot Following Ponseti Casting: A Retrospective Study.

The General Authority for Teaching Hospitals and Institutes1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Parents' compliance

研究概览

简要总结

This study aims to compare the effectiveness of the original Denis Brawn brace to its modification in managing relapsed idiopathic clubfoot in patients following Ponseti casting.

详细描述

Clubfoot is an intricate deformity of the ankle and foot involving bony malalignment, adduction of the forefoot, and hindfoot varus, cavus, and equinus caused by contracture of soft tissues.

Lack of compliance causes the majority of relapse, as the child may have problems sleeping and wearing the Dennis Brown Splint; that is why parental counseling is vital and very much important in this regard.

Bracing plays a vital role in the maintenance of corrected club foot and allows the foot to achieve normal position after tenotomy, followed by serial casting. Bracing holds the foot not in a corrected but in an overcorrected position so that the normal position of the foot could be achieved after the correction. Without bracing, it is almost impossible for the physician or the surgeon to maintain the correction.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age from 2 to 5 years.
  • Both sexes.
  • Relapsed cases.
  • Patients with idiopathic clubfoot.

排除标准

  • Neurological or syndromic involvement.
  • Presenting with skin or soft-tissue lesions around the foot and ankle.
  • Inadequate documentation.
  • Soft-tissue surgery is needed (except tendo-achilles tenotomy).
  • Irregular plaster casting schedule.

结局指标

主要结局

Parents' compliance

时间窗: 12 months post-procedure

Parents' compliance will be classified into three grades as follows: * Grade 0: poor follow-up with a lack of commitment in bracing hours (bad compliance). * Grade 1: an intermittent follow-up with a good commitment in bracing hours (intermediate compliance). * Grade 2: a good follow-up with a strict commitment in bracing hours (good compliance).

次要结局

  • Efficacy in maintaining correction measured by the Pirani score(12 months post-procedure)
  • Incidence of complications(12 months post-procedure)

研究者

发起方
The General Authority for Teaching Hospitals and Institutes
申办方类型
Network
责任方
Principal Investigator
主要研究者

Mahmoud Mohamed Abdallah

Orthopedic Surgery

The General Authority for Teaching Hospitals and Institutes

研究点 (1)

Loading locations...

相似试验