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

Study Overview
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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.

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.

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

Conditions
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Donor Site Complication, Muscle; Ischemic

Intervention / Treatment
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* Device: Elastography


Participation Criteria
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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 Exclusion Criteria: Previous major operations over either leg Unable to walk freely during daily life

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients after free flap harvested<br>Patients receiving peroneal artery-based free flap harvest | Device: Elastography<br>* Use elastography to evaluate the stiffness of lower leg muscle after peroneal artery-based free flap harvested<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Leg Muscle stiffness | Lower leg muscle stiffness after peroneal artery-based flap harvested; Name of measurement: elastic modulus; Unit: kPa | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Orthopedic Foot and Ankle (AOFAS) scale | AOFAS scale change after peroneal artery-based flap harvested, highest score:100, lowest score: 0; A higher score means a better outcome | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elastography; Donor site morbidity