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

This study has been completed.
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
Mayo Clinic
Information provided by (Responsible Party):
Kristen Leroy, Infoscitex Corporation
ClinicalTrials.gov Identifier:
NCT01309347
First received: March 3, 2011
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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.


Condition
Evaluation of a New Prosthetic Socket Liner Material.

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional

Further study details as provided by Infoscitex Corporation:

Enrollment: 6
Study Start Date: March 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study will be conducted at one prosthetic fabrication facility.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309347

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Infoscitex Corporation
U.S. Army Medical Research and Materiel Command
Mayo Clinic
Investigators
Principal Investigator: Kristen LeRoy Infoscitex Corporation
  More Information

No publications provided

Responsible Party: Kristen Leroy, Group Leader, Biomedical Devices, Infoscitex Corporation
ClinicalTrials.gov Identifier: NCT01309347     History of Changes
Other Study ID Numbers: IST-1288 Study I, W81XWH-07-C-0094
Study First Received: March 3, 2011
Last Updated: March 1, 2012
Health Authority: United States: Mayo Clinic Institutional Review Board

Keywords provided by Infoscitex Corporation:
prosthetic socket, residual limb volume fluctuation

ClinicalTrials.gov processed this record on April 17, 2014