Trans-femoral prosthetic socket for Prosthetics

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
ProstheticsTrans-femoral prosthetic socket - Device
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the effects of different types of prosthetic sockets on trans-femoral amputees in a randomized way. The findings of this trial will be used in a clinical setting to help fit trans-femoral amputees with prosthetic sockets.

Treatment Effectiveness

Study Objectives

3 Primary · 8 Secondary · Reporting Duration: 20 seconds

1 second
Residual Femur motion
Skin strain
Static displacement
20 seconds
Gait symmetry
Hip Range of Motion
Hip flexion/extension
Hip strength
Plantar pressure
Socket pressure
Trunk lean
3 seconds
Tissue Stiffness

Trial Safety

Trial Design

1 Treatment Group

Unmodified Socket + 8 Socket Modifications in Random Order
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Trans-femoral prosthetic socket · No Placebo Group · N/A

Unmodified Socket + 8 Socket Modifications in Random Order
Device
Experimental Group · 1 Intervention: Trans-femoral prosthetic socket · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 20 seconds

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,617 Previous Clinical Trials
16,295,412 Total Patients Enrolled
United States Department of DefenseFED
777 Previous Clinical Trials
202,467 Total Patients Enrolled
William Anderst, PhDPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
126 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a transfemoral prosthesis user.
You are able to walk unassisted on a treadmill.

Who else is applying?

What state do they live in?
New Jersey100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Pittsburgh100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%