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

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.

Study Overview

• Status: Completed
• Conditions: Evaluation of a New Prosthetic Socket Liner Material
• Intervention / Treatment: Device: Novel conformable woven inner socket

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.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subject will be selected from one prosthetic fabrication facility and recruited by their prosthetist

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lower Limb Amputees; Those with lower limb amputations	Device: Novel conformable woven inner socket; Prosthetic socket liner fabricated from novel materials to allow passive conformability for the user

Collaborators and Investigators

• Sponsor: Infoscitex Corporation
• Collaborators: Mayo Clinic; U.S. Army Medical Research and Development Command

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: October 17, 2011
• First Submitted That Met QC Criteria: October 17, 2011
• First Posted (ESTIMATE): October 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 5, 2012
• Last Update Submitted That Met QC Criteria: March 1, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: prosthetic socket; residual limb volume fluctuation; conformable socket liner
• Other Study ID Numbers: IST1288 Study 2; W81XWH-07-C-0094 (Other Grant/Funding Number: US Army / TATRC)