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

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:
NCT01455324
First received: October 17, 2011
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Evaluation of a New Prosthetic Socket Liner Material
Device: Novel conformable woven inner socket

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional

Further study details as provided by Infoscitex Corporation:

Enrollment: 1
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455324

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
  More Information

No publications provided

Responsible Party: Kristen Leroy, Group Leader, Biomedical Devices, Infoscitex Corporation
ClinicalTrials.gov Identifier: NCT01455324     History of Changes
Other Study ID Numbers: IST1288 Study 2, W81XWH-07-C-0094
Study First Received: October 17, 2011
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014