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

NCT ID: NCT02346019

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2020-03-31

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.

Conditions

Transfemoral Amputees

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Surgical: Medial thighplasty

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.

Group Type: EXPERIMENTAL

Medial thighplasty with or without thigh liposuction

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Todd Kuiken

Director, Center for Bionic Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Todd A Kuiken, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00090292

Identifier Type: -

Identifier Source: org_study_id