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Functional Performance Evaluation of NU-FlexSIV Socket

NCT02678247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-06-15

Study results available
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Summary

The overall objective of this study is to provide a more comfortable and functional prosthetic socket for persons with transfemoral amputation that will ultimately improve their quality of life.

Conditions

  • Amputation
  • Artificial Limbs

Interventions

DEVICE

Northwestern University Flexible Sub-Ischial Vacuum Socket

NU-FlexSIV sockets have lower proximal trim lines, do not impinge on the pelvis, are highly flexible so as to allow better comfort during sitting and when muscles move within the socket during activity, and are held securely to the residual limb by suction from a vacuum pump and from compression exerted by the deliberately undersized liner and socket.

DEVICE

Ischial Containment Socket

Ischial Containment (IC) sockets are more rigid and have a narrower medio-lateral dimension than anterior-posterior dimension. The socket encapsulates the ischium, ischial ramus and greater trochanter, limiting hip range of motion and comfort.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Jesse Brown VA Medical Center

    collaborator FED

  • Scheck and Siress

    collaborator INDUSTRY

  • Northwestern University

    lead OTHER

Principal Investigators

  • Stefania Fatone, PhD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02678247 on ClinicalTrials.gov