Overview

This trial is active, not recruiting.

Condition transfemoral amputees
Treatment medial thighplasty with or without thigh liposuction
Sponsor Rehabilitation Institute of Chicago
Start date August 2014
End date August 2017
Trial size 3 participants
Trial identifier NCT02346019, STU00090292

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
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.
medial thighplasty with or without thigh liposuction
Perform a standard medial thighplasty with or without additional thigh liposuction on up to three obese transfemoral amputee subjects. The subjects will be transfemoral amputees who are successful ambulators and have a body mass index (BMI) of 30 or greater with excessive adipose tissue in their residual limb. The surgery will consist of medial excision of excess adipose and cutaneous tissue with circumferential liposuction.

Primary Outcomes

Measure
Assess compliance of residual limb in the socket, which will improve the fit and comfort of the prosthesis.
time frame: Pre surgery and 6 months post surgery

Secondary Outcomes

Measure
Assess walking endurance
time frame: Pre surgery and 6 months post surgery
Assess balance stability
time frame: Pre surgery and 6 months post surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Thighplasty of Transfemoral Amputee Residual Limbs to Improve Prosthesis Fit and Patient Functional Outcomes
Principal investigator Todd A Kuiken, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Rehabilitation Institute of Chicago.