Accession Number:

AD1033393

Title:

Functional Performance Evaluation of the Northwestern University Flexible Subischial Vacuum (NU-FlexSIV) Socket for Persons with Transfemoral Amputation

Descriptive Note:

Technical Report,30 Sep 2015,29 Sep 2016

Corporate Author:

Northwestern University Evanston United States

Personal Author(s):

Report Date:

2016-10-01

Pagination or Media Count:

13.0

Abstract:

This project is a clinical trial to compare the new prosthetic socket we developed the Northwestern University Flexible Sub-Ischial Vacuum NU-FlexSIV Socket with the current standard of care socket the Ischial Containment IC Socket with the goal of demonstrating objective functional superiority as well as more desirable patient-reported outcome measures. The primary aims of the study are 1 to demonstrate if the NU-FlexSIV Socket is more comfortable than the IC Socket 2 to demonstrate if the NU-FlexSIV Socket results in better functional performance than the IC Socket and 3 to demonstrate if the NU-FlexSIV Socket will result in better quality of life and satisfaction with device i.e. prosthesis than the IC Socket. During year 1, we received all required IRB approvals, registered the clinical trial, and recruited our goal of 10 subjects five who are actively being tested and five who are awaiting socket fittingtesting.

Subject Categories:

  • Medicine and Medical Research
  • Medical Facilities, Equipment and Supplies
  • Anatomy and Physiology

Distribution Statement:

APPROVED FOR PUBLIC RELEASE