Evaluation of a Novel Transfemoral Prosthetic Socket System

Not Applicable

• Conditions: Lower Limb Amputation
• Interventions: Device: Conventional Prosthetic Transfemoral Socket System; Device: Novel Prosthetic transfemoral socket system

• Registration Number: NCT01846845
• Lead Sponsor: Ohio Willow Wood

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-01
• Study First Posted: 2013-05-03
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-27
• Last Update Posted: 2013-07-01
• Primary Completion: 2014-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional TF Socket System	Conventional Prosthetic Transfemoral Socket System	Conventional Prosthetic Transfemoral Socket System
Novel TF Socket System	Novel Prosthetic transfemoral socket system	Novel Prosthetic Transfemoral Socket System

Primary Outcome Measures

Name	Time	Method
Laser Doppler flowmetry tissue perfusion values	1 month	Change from baseline in Laser Doppler flowmetry tissue perfusion values at 1 month

Secondary Outcome Measures

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

Trial Locations

Locations (2)

The Ohio Willow Wood Company; 🇺🇸 Mt. Sterling, Ohio, United States

The Ohio State University Davis Heart and Lung Research Institute; 🇺🇸 Columbus, Ohio, United States