Evaluation of the Development of an Advanced, Conformable Prosthetic Socket, Study I

NCT ID: NCT01309347

Last Updated: 2012-03-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-04-30

Brief Summary

The purpose of this study is obtain prosthetist's feedback on the novel conformable socket material developed by Infoscitex, and determine if it is a viable alternative to current prosthetic socket liners. During this task, the research team will travel to the prosthetists locations to have them evaluate the socket system by examining the material and providing their professional opinions and feedback with regard to comfort and fit for the amputee, its ease of use, and breathability.

Detailed Description

Modern prosthetics have improved significantly with regards to control and functionality, but the fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. The volume of the residual limb of an amputee changes throughout the course of a day and throughout the year. Volume fluctuation within the socket can lead to issues for the amputee, including decreased comfort, increased shear forces, increased pressure on bony prominences, as well as a poor gait pattern. An uncomfortable or non-performing socket/residual limb interface decreases user compliance with the prosthetic and therefore decreases the activity level of amputees who want to remain active in their civilian and military lives.

The investigators are developing a multilayered socket that takes advantage of a novel braided material for strength and passive conformability with thin layers dedicated to wearer comfort. This new socket provides ultimate fit for improvement in the performance of the prosthesis. The socket adapts itself to the changing physical shape of the residual limb as the prosthesis is worn. The adaptation is a natural result of the material properties, so is done passively and in real time. The materials are lightweight, breathable, and ultrasound transparent, allowing the prosthetic to function in a variety of environments.

This study will be undertaken to have six prosthetists evaluate the material, where they will be asked to complete a questionnaire and give their opinions regarding the material. This will inform design changes for the material.

Conditions

Evaluation of a New Prosthetic Socket Liner Material.

Study Design

• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• prosthetists who are active professionals and have clients (or have had clients in the past 6 months)

Exclusion Criteria

• prosthetists who are not American Board for Certification of Orthotics and Prosthetics certified

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

Infoscitex Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Kristen Leroy

Group Leader, Biomedical Devices

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristen LeRoy

Role: PRINCIPAL_INVESTIGATOR

Infoscitex Corporation

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

W81XWH-07-C-0094

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IST-1288 Study I

Identifier Type: -

Identifier Source: org_study_id