CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Northwestern University Flexible Sub-Ischial Vacuum Socket +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02678247
NCT02678247N/ACompleted
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Functional Performance Evaluation of the Northwestern University Flexible Sub-Ischial Vacuum (NU-FlexSIV) Socket for Persons With Transfemoral Amputation

Northwestern University·interventional·Posted Feb 9, 2016·Updated Jun 15, 2021

In Brief

A clinical study evaluating Northwestern University Flexible Sub-Ischial Vacuum Socket and Ischial Containment Socket for Amputation and Artificial Limbs. Completed, enrolled 30 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmputation, Artificial Limbs
CountriesUnited States
CollaboratorsUnited States Department of Defense, Jesse Brown VA Medical Center, Scheck and Siress

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 9, 2016
Enrollment StartApr 1, 2016
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 10.4 years ago

Interventions

Northwestern University Flexible Sub-Ischial Vacuum Socketdevice

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.

Ischial Containment Socketdevice

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.