跳至主要内容
临床试验/CTRI/2024/07/070386
CTRI/2024/07/070386尚未招募不适用

Comparison of Reinforced and Standard cast for post tenotomy Clubfoot Children

Chacha Nehru Bal Chikitsalaya1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Compare cast characteristics of reinforced and standard casts in post tenotomy clubfoot patients

研究概览

简要总结

Ponseti method consists of specific technique of manipulation and cast application with foot in corrected position. Correction of equinus deformity in clubfoot patients requires percutaneous tendoachilles tenotomy followed by cast application in complete dorsiflexion to maintain the correction achieved for 3 weeks. Since this cast may be subjected to physiological activities of an active child, it may lose its integrity, bringing change in cast characteristics leading to loss of correction achieved at application. Also it is observed at 3 weeks follow up the breakage of cast at knee and ankle region leading to loss of ankle dorsiflexion. There are no previous studies to determine the cast characteristics to preserve ankle dorsiflexion so our study plans to explore this aspect of Ponseti casting in active child.

Aim: Compare cast characteristics for reinforced and standard casts for post tenotomy clubfoot children on removal

Objectives: 1) To compare the cast characteristics for reinforced casts and standard casts in post tenotomy patients

2 ) To compare ankle dorsiflexion clinically prior to cast application and on removal

 3) To evaluate gap index and ankle dorsiflexion in the post tenotomy casts radiologically

 Methodology : 30 bilateral idiopathic clubfoot children meeting the inclusion and exclusion criteria who are undergoing tenotomy will be enrolled. Post tenotomy clinical dorsiflexion will be measured and casts will be applied according to standard technique in one limb and reinforcement will be done at knee and planter aspect of foot in the other after placement of radiopaque markers. Lateral foot radiographs will be obtained and gap index, radiological dorsiflexion and cast dorsiflexion will be measured.

Outcome Measures: Cast characteristics will be recorded in terms of moulding, flexion at knee, dorsiflexion at ankle and extent after application. Lateral foot radiographs will be obtained and gap index, radiological dorsiflexion and cast dorsiflexion will be measured. At 3 weeks follow up change in cast characteristics in terms of breakage at knee and ankle, slippage and weight will be recorded. The loss of clinical dorsiflexion (if any) after cast removal will be calculated and correlated with the cast characteristics to determine the effect of reinforcement of cast and preservation of ankle dorsiflexion.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
0.00 Day(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Idiopathic clubfoot children with bilateral clubfeet undergoing Achilles tenotomy for correction of ankle equinus.

排除标准

  • Syndromic, neurological, complex, previously operated and relapsed clubfeet 2)Clubfoot children where tenotomy is not required for correction of ankle equinus or Achilles tenotomy is required for only one foot.

结局指标

主要结局

Compare cast characteristics of reinforced and standard casts in post tenotomy clubfoot patients

时间窗: 3 weeks

次要结局

  • 1) To compare ankle dorsiflexion clinically prior to cast application and on removal

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Anil Agarwal

Chacha Nehru Bal Chikitsalaya

研究点 (1)

Loading locations...

相似试验