Expired Study
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Chicago, Illinois 60611


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT02346019


Primary Contact:

Principal Investigator
Todd A Kuiken, MD, PhD
Shirley Ryan AbilityLab


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60611
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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