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临床试验/NCT03887585
NCT03887585Unknown不适用

Modified Percutaneous Achilles Tendon Lengthening by Triple Hemisection for Achilles Tendon Contracture

Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
25
试验地点
1
主要终点
Changes in the American Orthopaedic Foot & Ankle Society (AOFAS) scores

研究概览

简要总结

This study aims to evaluate the efficacy and safety of this new therapeutic method, which is based on the percutaneous sliding technique with three hemi-cuts in the tendon.

详细描述

This study aims to provide a new therapeutic theory which bases on the percutaneous sliding technique with three hemi-cuts in the tendon. In this study, Achilles tendon parenchymal at distal level is hemisected through the most distal incision, Achilles tendon parenchymal at proximal level is hemisected through the middle incision, then Achilles tendon lengthening is accomplished by the sliding tendon under forceful dorsiflexion. It can better achieve soft tissue balance and reduce the recurrence of Achilles tendon contracture when Achilles tendon strength in plantarflexion is weakened. Thus in this study, the partial aponeurosis of gastrocnemius is cut off at most proximal incision in order to weaken Achilles tendon strength in plantarflexion.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than three years old;
  • Severe Achilles tendon contracture and equinus;
  • The time after Achilles tendon contracture more than 6 months ;
  • Initial Achilles tendon lengthening.

排除标准

  • Patients younger than 3 years;
  • The course of Achilles tendon contracture is within 6 months;
  • Patients who have suffered from the Achilles tendon lengthening;
  • Obvious contracture of other soft tissues occurs in combination, such as compartment syndrome or extensive scar tissues in calf;
  • Osteotomy or tendon transposition is needed.
  • Ankle joint is damaged obviously, such as Charcot's joint or Hemophilic arthritis;
  • Skin soft-tissue infection in the lower limb.
  • Initial Achilles tendon lengthening.

结局指标

主要结局

Changes in the American Orthopaedic Foot & Ankle Society (AOFAS) scores

时间窗: Before surgery and up to 8 years after surgery

The AOFAS scores of the patients before and after surgery are recorded. The scale ranges from 0-100 points, and increases of the value represent a better outcome.

次要结局

  • Equinus recurrence rate(Up to 8 years after surgery)
  • Infection rate(Up to 8 years after surgery)

研究者

发起方
Southwest Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaojun Duan

vice dean

Southwest Hospital, China

研究点 (1)

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