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

NCT02346019 | Completed

• 1 other identifier: STU00090292
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Transfemoral Amputees

Outcome Measures

Primary Outcomes (1)

• Assess compliance of residual limb in the socket, which will improve the fit and comfort of the prosthesis.

  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.

  Pre surgery and 6 months post surgery

Secondary Outcomes (2)

• Assess walking endurance

  Pre surgery and 6 months post surgery

• Assess balance stability

  Pre surgery and 6 months post surgery

Study Arms (1)

Surgical: Medial thighplasty

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.

Procedure: Medial thighplasty with or without thigh liposuction

Interventions

Medial thighplasty with or without thigh liposuction 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.

Surgical: Medial thighplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Study Officials

• Todd A Kuiken, MD, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Bionic Medicine

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 26, 2015
• Study Start: August 1, 2014
• Primary Completion: August 1, 2019
• Study Completion: March 1, 2020
• Last Updated: March 23, 2020

Record last verified: 2020-03

Locations

US (1)