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

Shirley Ryan AbilityLab

Status: Completed

Conditions: Transfemoral Amputees

Treatments: Procedure: Medial thighplasty with or without thigh liposuction

Study type: Interventional

Funder types: Other

Identifiers

NCT02346019

STU00090292

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Surgical: Medial thighplasty

Experimental group

Description:

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.

Treatment:

Procedure: Medial thighplasty with or without thigh liposuction