Change in the Lower Leg Muscle Stiffness Following Peroneal Artery-based Flap

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-22

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Donor Site Complication Muscle; Ischemic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients after free flap harvested

Patients receiving peroneal artery-based free flap harvest

Group Type EXPERIMENTAL

Elastography

Intervention Type DEVICE

Use elastography to evaluate the stiffness of lower leg muscle after peroneal artery-based free flap harvested

Interventions

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Elastography

Use elastography to evaluate the stiffness of lower leg muscle after peroneal artery-based free flap harvested

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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