Thigh Reduction Surgery of Above Knee Amputee Residual Limbs to Improve Prosthesis Fit and Patient Outcomes

Not Applicable

Completed

• Conditions: Transfemoral Amputees
• Interventions: Procedure: Medial thighplasty with or without thigh liposuction

• Registration Number: NCT02346019
• Lead Sponsor: Shirley Ryan AbilityLab

Brief Summary

The purpose of our study is to improve the fit and function of prosthetic sockets for above the knee amputees through the use of an outpatient thigh reduction surgical procedure.

Detailed Description

We will quantify the anatomical distribution of subcutaneous fat, muscle and bone in the residual limb of the transfemoral amputees with an MRI. We will measure the displacement of the socket wall relative to the femur under mechanical loading with x-ray. The functional mobility level of the subject with be quantified via standard clinical and bio mechanical tests. Perform a standard medial thighplasty with our without thigh liposuction. Characterize the post-surgical anatomy, compliance of the residual limb and function of the amputee subjects. After six months, repeat the MRI and xray and compare results. Subject will also complete a questionnaire regarding their views on the outcome of the surgery.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-19
• Study First Posted: 2015-01-26
• Primary Completion: 2019-08
• Status Verified: 2020-03
• Study Completion: 2020-03
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Obese transfemoral amputees with a BMI of at least 30.
• Mid to long residual limb, excessive adipose tissue in their residual limb
• Community ambulators
• Adults over the age of 18

Exclusion Criteria

• Amputation due to vascular disease or diabetes
• Cognitive impairments that would interfere with the protocol or patient safety
• Systemic disease that is not stable or would significantly increase the risk of complications with surgery
• Chronic wounds
• People who do not ambulate on a daily basis
• Children under the age of 18.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical: Medial thighplasty	Medial thighplasty with or without thigh liposuction	Perform a standard medial thighplasty with our without additional thigh liposuction on up to three obese transfemoral amputee subjects. The surgery will consist of medial excision of excess adipose and cutaneous tissue with circumferential liposuction.

Primary Outcome Measures

Name	Time	Method
Assess compliance of residual limb in the socket, which will improve the fit and comfort of the prosthesis.	Pre surgery and 6 months post surgery	We will measure the compliance of their residual limb by the displacement of the socket wall relative to the femur under mechanical loading with X-ray. The subjects will adjust their foot placement, limb loading and muscle contractions to achieve up to 8 specified force/torque levels (as measured by a 6 degree-of-freedom load cell located in series with their pylon and socket), which correspond to forces and torques that are typical of over ground walking and standing postures and are scaled for their body weight. For each force/torque level, static X-ray scans of locations of the prosthetic socket wall and residual limb femur will be acquired.

Secondary Outcome Measures

Name	Time	Method
Assess walking endurance	Pre surgery and 6 months post surgery	Complete 6 minute walk test over level ground as metabolic energy consumption and heart rate our monitored. Subjects may wear a portable, commercially available metabolic measurement system so that their metabolic energy expenditure may be calculated after the experiment.
Assess balance stability	Pre surgery and 6 months post surgery	Complete the 4 square step test as a clinical test of the ability to change directions while stepping.

Trial Locations

Locations (1)

Rehabilitation Institute of Chicago; 🇺🇸 Chicago, Illinois, United States