Evaluation of the Development of an Advanced, Conformable Prosthetic Socket, Study II
|Evaluation of a New Prosthetic Socket Liner Material||Device: Novel conformable woven inner socket|
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Study Start Date:||September 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455324
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|