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A Comparative Assessment of Transfemoral Prosthetic Sockets

NCT04038580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-09-29

Study results available
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Summary

The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.

Conditions

  • Amputation
  • Amputation; Traumatic, Leg, Lower

Interventions

DEVICE

Laminated Socket

This is the currently prescribed socket the participant normally wears.

DEVICE

Quatro

The Quatro (Quorum) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.

DEVICE

Infinite Socket

The Infinite Socket (LiM Innovations) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.

DEVICE

CJ Socket

The CJ Socket (CJ Socket Technologies) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.

Sponsors & Collaborators

Principal Investigators

  • Deanna H Gates, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2024-07-01
Completion
2024-07-01
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 NCT04038580 on ClinicalTrials.gov