跳至主要内容
临床试验/NCT04692961
NCT04692961已完成不适用

Change in the Lower Leg Muscle Stiffness Following Peroneal Artery-based Flap: An Elastography Ultrasonographic Study

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2020年12月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
Lower Leg Muscle stiffness

研究概览

简要总结

In the field of reconstructive microsurgery, donor site morbidity after free flap harvest is one of the key factors to consider when choosing among different options of free flap. Peroneal artery-based free flap, such as fibula flap or peroneal flap, is one of the popular options of free flap. There are a plenty of literature using a variety of modalities to evaluate the donor site morbidity after free fibula harvest, such as gait analysis. Elastography has been used to evaluate the stiffness change of soft tissue, such as skeletal muscle, or liver. The purpose of this study is to use elastography to evaluate the stiffness of lower leg muscle after peroneal artery-based free flap harvest.

详细描述

A total of twenty-three patients will be recruited at National Taiwan University Hospital Yunlin Branch. All of them will receive fibula flap or peroneal flap harvest operations. At the time points of pre-operation, 1-month post-operation, 3-month post-operation, and 6-month post-operation, the muscles of both legs of each patient will be evaluated by elastography, and the function of both legs will be evaluated by American Orthopedic Foot and Ankle Score (AOFAS). Paired t-test will be used to compare the results of each evaluations.

研究设计

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

入排标准

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

入选标准

  • No previous major operations over both legs
  • Able to walk freely during daily life
  • Going to receive peroneal artery-based free flap harvested from one leg

排除标准

  • Previous major operations over either leg
  • Unable to walk freely during daily life

研究组 & 干预措施

Patients after free flap harvested

Experimental

Patients receiving peroneal artery-based free flap harvest

干预措施: Elastography (Device)

结局指标

主要结局

Lower Leg Muscle stiffness

时间窗: 6 months

Lower leg muscle stiffness after peroneal artery-based flap harvested; Name of measurement: elastic modulus; Unit: kPa

次要结局

  • American Orthopedic Foot and Ankle (AOFAS) scale(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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