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

Donor Site Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04692961
• Other study ID #: 202009077RIND
• Status: Completed
• Phase: N/A
• Start date: December 22, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 31, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Donor Site Complication
• Muscle; Ischemic

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Yunlin Branch	Douliu	Yunlin County

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower Leg Muscle stiffness	Lower leg muscle stiffness after peroneal artery-based flap harvested; Name of measurement: elastic modulus; Unit: kPa	6 months
Secondary	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