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

Transfemoral Amputees Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346019
• Other study ID #: STU00090292
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: March 2020

Study information

• Verified date: March 2020
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: March 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Transfemoral Amputees

Intervention

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.

Locations

Country	Name	City	State
United States	Rehabilitation Institute of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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