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

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 fitting/testing).

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2016
Accession Number
AD1033393

Entities

People

  • Stefania Fatone

Organizations

  • Northwestern University

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Amputation
  • Amputees
  • Clinical Trials
  • Data Analysis
  • Lower Limb Amputations
  • Lower Limb Amputees
  • Personnel Management
  • Prostheses And Implants
  • Prosthetics
  • Quality Of Life
  • Standards
  • Surgical Amputations
  • Test And Evaluation
  • Universities

Readers

  • Clinical Trial Research.
  • Rehabilitation and Prosthetic Care for Military Service Members and Veterans with Limb Loss or Disability.