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

Thighplasty of Transfemoral Amputee Residual Limbs to Improve Prosthesis Fit and Patient Functional Outcomes

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 Overview

• Status: Completed
• Conditions: Transfemoral Amputees
• Intervention / Treatment: Procedure: Medial thighplasty with or without thigh liposuction

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Rehabilitation Institute of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess walking endurance	Complete 6 minute walk test over level ground as metabolic energy consumption and heart rate our monitored. Subjects may wear a portable, commercially available metabolic measurement system so that their metabolic energy expenditure may be calculated after the experiment.	Pre surgery and 6 months post surgery
Assess balance stability	Complete the 4 square step test as a clinical test of the ability to change directions while stepping.	Pre surgery and 6 months post surgery

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: January 9, 2015
• First Submitted That Met QC Criteria: January 19, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: STU00090292