Evaluation of a Novel Transfemoral Prosthetic Socket System

Study Overview
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Brief Summary
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The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a novel prosthetic transfemoral socket system. A conventional prosthesis will be compared to the novel transfemoral socket system.

Detailed Description
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Conventional transfemoral socket designs impose an array of limitations on transfemoral amputee patients. Flexion, extension, and abduction are considerably impaired and end basic functions like sitting are usually uncomfortable or even painful. An alternative socket design that lowers the socket trim-lines and still provides structural support would greatly improve the socket comfort for transfemoral amputees.

Official Title
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Prosthetic Socket System: Pilot Assessment

Conditions
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Lower Limb Amputation

Intervention / Treatment
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* Device: Conventional Prosthetic Transfemoral Socket System
* Device: Novel Prosthetic transfemoral socket system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consenting Adult Unilateral transfemoral amputee Currently suing a liner with prosthesis Uses a prosthesis to ambulate Ability to read, write, and understand English Available during regular business hours for appointments Exclusion Criteria: Impaired contra lateral leg Ambulates with the aid of an additional assistive device (e.g. walker, cane, etc.) Diagnosis of renal failure Smoker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional TF Socket System<br>Conventional Prosthetic Transfemoral Socket System | Device: Conventional Prosthetic Transfemoral Socket System<br>* Conventional transfemoral may include an ischial containment socket, a pin suspension socket, and/or suction suspension socket<br>* Other names: Above the knee (AK) socket;|
| Experimental: Novel TF Socket System<br>Novel Prosthetic Transfemoral Socket System | Device: Novel Prosthetic transfemoral socket system<br>* Prosthetic socket that incorporates lower socket trim-lines and transfemoral vacuum suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laser Doppler flowmetry tissue perfusion values | Change from baseline in Laser Doppler flowmetry tissue perfusion values at 1 month | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laser speckle flowmetry tissue perfusion values | Change from baseline in laser speckle flowmetry tissue perfusion values at 1 month | 1 month | 
| Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) | Change from baseline in hyperspectral imaging StO2% at 1 month | 1 month | 
| Trans-Epidermal Water Loss values | Change from baseline in trans-epidermal water loss values at 1 month | 1 month | 
| Surface electrical capacitance values | Change from baseline in surface electrical capacitance values at 1 month | 1 month | 
| Elasticity (cutometry) values | Change from baseline in elasticity values at 1 month | 1 month | 
| Torsional Ballistometry values | Change from baseline in torsional ballistometry values at 1 month | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputee