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Sub-Ischial Socket for Transfemoral Amputation and Lower Mobility

NCT05662982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-12-15

No results posted yet for this study

Summary

The objective of this trial is to assess use and benefits of the subischial socket for persons with transfemoral amputation and lower mobility levels. Specifically, the investigators will evaluate whether the subischial socket improves comfort, socket wear time, mobility, participation, quality of life and satisfaction with device than the standard-of-care ischial containment socket.

Conditions

  • Transfemoral Amputation

Interventions

DEVICE

Northwestern University Flexible Subischial Suction Socket (NU-FlexSIS)

A custom-made prosthetic socket for transfemoral amputation that consists of proximal trimlines that do not interact with the pelvis.

Sponsors & Collaborators

Principal Investigators

  • Stefania Fatone, PhD · University of Washington

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-11-30
Completion
2025-11-30
FDA Device
Yes

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 NCT05662982 on ClinicalTrials.gov