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

NCT04692961 | Completed

• 1 other identifier: 202009077RIND
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Donor Site Complication; Muscle; Ischemic

Keywords

Elastography; Donor site morbidity

Outcome Measures

Primary Outcomes (1)

• Lower Leg Muscle stiffness

  Lower leg muscle stiffness after peroneal artery-based flap harvested; Name of measurement: elastic modulus; Unit: kPa

  6 months

Secondary Outcomes (1)

• American Orthopedic Foot and Ankle (AOFAS) scale

  6 months

Study Arms (1)

Patients after free flap harvested

EXPERIMENTAL

Patients receiving peroneal artery-based free flap harvest

Device: Elastography

Interventions

Elastography DEVICE

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

Patients after free flap harvested

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Yunlin Branch

Douliu, Yunlin County, Taiwan

Location

MeSH Terms

Conditions

Ischemia

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ying-Sheng Lin, MD, MPH

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 5, 2021
• Study Start: December 22, 2020
• Primary Completion: June 1, 2023
• Study Completion: December 31, 2023
• Last Updated: March 19, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)