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

NCT ID: NCT01455324

Last Updated: 2012-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-12-31

Brief Summary

The purpose of this study is to work with prosthetists to fit the novel conformable socket material developed by Infoscitex, to subjects, 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 fit the subject with the conformable woven socket and a check socket, and provide subjective feedback with regard to comfort and fit for the amputee, its ease of use, and breathability. The subject will also wear the woven socket for gait analysis and provide his/her feedback as well.

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 prosthetists fit subject lower limb amputees with the woven inner socket, with a check socket for evaluation in a gait lab setting. At the completion, the subject and prosthetists will be asked to complete a questionnaire and give their opinions regarding the material of the woven inner socket.

Conditions

Evaluation of a New Prosthetic Socket Liner Material

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Lower Limb Amputees

Those with lower limb amputations

Novel conformable woven inner socket

Intervention Type: DEVICE

Prosthetic socket liner fabricated from novel materials to allow passive conformability for the user

Interventions

Novel conformable woven inner socket

Prosthetic socket liner fabricated from novel materials to allow passive conformability for the user

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• lower limb amputation
• stable residual limb volume
• loss of limb due to trauma
• at least 18 years of age

Exclusion Criteria

• evidence or history of neuropathy
• presence of phantom limb pain

• Minimum Eligible Age: 18 Years
• 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

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

W81XWH-07-C-0094

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IST1288 Study 2

Identifier Type: -

Identifier Source: org_study_id