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

Not Applicable

Completed

• Conditions: Donor Site Complication; Muscle; Ischemic
• Interventions: Device: Elastography

• Registration Number: NCT04692961
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-12-22
• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Status Verified: 2023-02
• Primary Completion: 2023-06-01
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients after free flap harvested	Elastography	Patients receiving peroneal artery-based free flap harvest

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital Yunlin Branch; 🇨🇳 Douliu, Yunlin County, Taiwan