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

National Taiwan University

Status: Completed

Conditions: Donor Site Complication; Muscle; Ischemic

Treatments: Device: Elastography

Study type: Interventional

Funder types: Other

Identifiers

NCT04692961

202009077RIND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Patients after free flap harvested

Experimental group

Description:

Patients receiving peroneal artery-based free flap harvest

Treatment:

Device: Elastography