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临床试验/NCT06300645
NCT06300645Enrolling By Invitation不适用

Split Tibialis Anterior Tendon Transfer to Peroneus Brevis vs Total Tibialis Anterior Tendon Transfer to Lateral Cuneiform in Recurrent Congenital Talipes Equinovarus: A Randomized Controlled Trial

Assiut University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年1月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
25
试验地点
2
主要终点
Correction of recurrent congenital talipes

研究概览

简要总结

Congenital talipes equinovarus, is a common congenital foot deformity involving hindfoot equinus and varus, along with mid-/forefoot adduction and cavus. Currently, the Ponseti method is the preferred initial treatment for idiopathic clubfoot1

. Despite the initial phase's remarkable efficacy in correcting clubfeet, there remains a notable recurrence rate after Ponseti treatment2

  • Numerous studies demonstrate a very high success rate during early follow-ups, ranging from 92% to 100%3
  • Nonetheless, recurrence remains a challenge for orthopedic surgeons. A common trigger for recurrence is the dynamic supination of the foot, which results from excessive activation of the tibialis anterior muscle during ankle dorsiflexion4

Multiple studies indicate that tibialis anterior tendon transfer (TATT) is an effective tool for management of clubfoot recurrence, particularly dynamic supination5

  • The widely used technique involves transferring the entire tendon through a drill hole in the lateral cuneiform and anchoring it on the plantar aspect of the foot using a sewing button and felt pad6
  • While effective, this procedure raises the risk of pressure sores due to button placement on the sole7

Split anterior tibialis tendon transfer (SPLATT) to peroneus brevis is a well-described treatment strategy of varus foot deformities in patients with neuromuscular disorders8

  • The technique has been reported to achieve successful deformity correction while avoiding skin problems associated with external button placement on the sole of the foot in tendon-to-bone transfers8

The present study aims to assess the outcome of utilizing SPLATT to peroneus brevis procedure in the treatment of recurrent CTEV in comparison to the original total TATT to the lateral cuneiform

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
Single (Participant)

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Recurrent CTEV
  • Age between 4 years and 12 years
  • Unilateral/bilateral
  • Ankle dorsiflexion of at least 10° prior to tendon transfer

排除标准

  • Non idiopathic CTEV
  • Rigid deformity not suitable for acute correction
  • Poor skin condition

研究组 & 干预措施

SPLATT

Experimental

Children with congenital talipes who have been treated with split tibialis anterior tendon transfer to peroneus brevis

干预措施: SPLATT (Procedure)

TATT

Experimental

Children with congenital talipes who have been treated with total ribialis anterior tendon transfer to lateral cuneiform

干预措施: SPLATT (Procedure)

结局指标

主要结局

Correction of recurrent congenital talipes

时间窗: 1 year

correction is measured by arc of eversion

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Yahya Abdelazeem Hassanein

Resident

Assiut University

研究点 (2)

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