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临床试验/NCT07473908
NCT07473908尚未招募不适用

Measurement of Achilles Tendon-neurovascular Distance Bilaterally in Infants With Unilateral Clubfoot Deformity

Assiut University0 个研究点目标入组 40 人开始时间: 2026年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
To measure the distance between the Achilles tendon and: • The posterior tibial neurovascular bundle In the clubfoot vs the normal foot

研究概览

简要总结

This study aims to assess the distance between the Achilles tendon and nearby neurovascular bundles bilaterally in infants with unilateral clubfoot deformity using ultrasound (US)- Doppler at 1 cm and 2 cm above the calcaneal tuberosity.

详细描述

Idiopathic clubfoot is a congenital deformity affecting the musculoskeletal structure of the foot .The Ponseti method remains the gold standard for its correction, culminating with a percutaneous Achilles tenotomy (1). Treatment of clubfoot with the Ponseti method has improved anatomical and functional results and reduced the number of surgical interventions required (4,7). In 80-90% of cases, a percutaneous tenotomy of the Achilles tendon is needed at 3-4 months of age, if the equinus position of the foot persists after corrective casts, and if the dorsiflexion of the ankle is less than 10º (7). The surgery is often performed as an outpatient procedure under local anesthesia and seems to be low risk. However, a complication rate of up to 4 % has been recorded , and the complications include pseudoaneurysm, necrosis, or gangrene of the foot that underwent intervention (7). The safety of this procedure critically depends on the spatial relationship between the Achilles tendon and adjacent neurovascular structures (6). Our objective is to study the use of ultrasound (US)- Doppler before Achilles tendon tenotomy bilaterally to determine the distance between the tendon and the posterior tibial neurovascular bundle in infants with unilateral clubfoot .

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
1 Month 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants aged 1-6 months
  • Unilateral clubfoot deformity and a normal opposite foot

排除标准

  • Non-idiopathic or syndromic clubfoot
  • Previous foot surgery , contralateral foot deformity

研究组 & 干预措施

normal foot

干预措施: ultrasound (Device)

clubfoot

干预措施: ultrasound (Device)

结局指标

主要结局

To measure the distance between the Achilles tendon and: • The posterior tibial neurovascular bundle In the clubfoot vs the normal foot

时间窗: baseline

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 samir

doctor

Assiut University

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