Improving prosthetic socket design for better patient outcomes
Improving Physical Function and Patient-reported Outcomes Through a Quantitatively-informed Socket Design Process
This study is testing new designs for prosthetic sockets to see if they can improve comfort and function for people with amputations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Pittsburgh, Pennsylvania and 1 other locations) |
| Trial ID | NCT05041998 on ClinicalTrials.gov |
What this trial studies
This study investigates how specific modifications to trans-femoral prosthetic sockets affect the mechanics of the residual limb and skin. Using a randomized within-subject design, the research aims to establish a quantitatively informed optimization process for socket design, moving away from traditional trial-and-error methods. The study will identify key mechanical characteristics related to patient comfort and function, and correlate these with conventional clinical measurements. The findings will lay the groundwork for a future clinical trial to validate the optimized fitting method.
Who should consider this trial
Good fit: Ideal candidates for this study are transfemoral prosthesis users aged 18-80 who can walk unassisted on a treadmill and weigh less than 125 kg.
Not a fit: Patients who are pregnant, have clinically diagnosed osteoporosis, or have had previous high exposure to radiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved comfort and function for lower limb amputees using prosthetic sockets.
How similar studies have performed: While this approach is innovative, there is limited existing data on the specific effects of socket design modifications on patient outcomes, making this study a novel exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Transfemoral prosthesis user * 18-80 years of age * Body weight less than 125 kg * Able to walk unassisted on a treadmill Exclusion Criteria: * Pregnant females * Clinically diagnosed osteoporosis * Previous high exposure to radiation
Where this trial is running
Pittsburgh, Pennsylvania and 1 other locations
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- Delatorre Orthotics & Prosthetics — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: William Anderst, PhD — University of Pittsburgh
- Study coordinator: Goeran Fiedler, PhD
- Email: gfiedler@pitt.edu
- Phone: 14126246475
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.