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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04692961
Enrollment
9
Registered
2021-01-05
Start date
2020-12-22
Completion date
2023-12-31
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Donor Site Complication, Muscle; Ischemic

Keywords

Elastography; Donor site morbidity

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.

Interventions

DEVICEElastography

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Lower Leg Muscle stiffness6 monthsLower leg muscle stiffness after peroneal artery-based flap harvested; Name of measurement: elastic modulus; Unit: kPa

Secondary

MeasureTime frameDescription
American Orthopedic Foot and Ankle (AOFAS) scale6 monthsAOFAS scale change after peroneal artery-based flap harvested, highest score:100, lowest score: 0; A higher score means a better outcome

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026