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
Effectiveness Progress
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
Safety Progress
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: DeviceTrial 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 Jersey | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of Pittsburgh | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Anderst, William, Goeran Fiedler, Kentaro Onishi, Gina McKernan, Tom Gale, and Paige Paulus. 2022. “Within-subject Effects of Standardized Prosthetic Socket Modifications on Physical Function and Patient-reported Outcomes”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-022-06205-z.
- William Anderst 2021. "Quantitatively-informed Socket Design Process". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05041998.
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