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

Abstract

This project was 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). The primary aims of the study were to (1) assess if the NU-FlexSIV Socket was more comfortable than the IC Socket; (2) to assess if the NU-FlexSIV Socket resulted in better functional performance than the IC Socket; and (3) to assess if the NU-FlexSIV Socket resulted in better quality of life and satisfaction with device (i.e. prosthesis) than the IC Socket. We enrolled 30 participants and 25 completed the study with full (n=18) or partial data (n=7). The results suggest that, after 7 weeks accommodation, the NU-FlexSIV Socket was significantly more comfortable and led to significantly greater satisfaction with device than the IC Socket in persons with unilateral transfemoral amputation with relatively high mobility. Other patient-reported outcomes, timed performance tests, and gait biomechanics were no different between sockets.

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Document Details

Document Type
Technical Report
Publication Date
Dec 01, 2020
Accession Number
AD1133052

Entities

People

  • Stefania Fatone

Organizations

  • Northwestern University

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • African Americans
  • Amputees
  • Biomedical Research
  • Clinical Trials
  • Data Analysis
  • Department Of Defense
  • Lower Limb Amputations
  • Medical Personnel
  • Pain
  • Performance Tests
  • Prostheses And Implants
  • Prosthetics
  • Quality Of Life
  • Residual Limbs
  • Statistical Analysis
  • Surgical Amputations
  • Test And Evaluation

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