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Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee

NCT02773056 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-04-03

No results posted yet for this study

Summary

The primary objective of this clinical trial is to determine if the Dynamic Socket and Sub-Ischial alternative interface designs improve socket comfort, residual limb health, increase function and be preferred over the standard of care Ischial Ramus Containment (IRC) interface for the military and veteran living with transfemoral limb loss.

Conditions

  • Amputation

Interventions

DEVICE

Ischial Ramus Containment (IRC)

Ischial Ramus Containment (IRC) is the standard of care socket

DEVICE

Dynamic Socket Ischial Ramus Containment (IRC)

Dynamic Socket Ischial Ramus Containment (IRC) is a comparator study socket

DEVICE

Sub-Ischial Interface (Sub-I)

Sub-Ischial Interface (Sub-I) is a comparator study socket

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of South Florida

    lead OTHER

Principal Investigators

  • Jason Highsmith, PhD, CP, PT · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-03-30
Completion
2018-03-30

Countries

  • United States

Study Locations

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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 NCT02773056 on ClinicalTrials.gov