A more comfortable, breathable transradial socket and harness for arm prostheses
Official title: The Advancement of a New Variable-Compliance Socket and Frame System for Transradial Amputees to Optimize Socket Fit and Upper Limb Function
Run by VA Office of Research and Development · NCT05990062 · Data updated 2026-11-12
This project will test a new hybrid polymer-and-textile transradial socket and harness to see if it improves comfort, breathability, and function for people with a unilateral transradial amputation.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | May 31, 2028 |
| Study ends | September 30, 2028 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT05990062 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a unilateral transradial amputation who currently wear a functioning prosthetic, have a residual limb of at least 4 inches and within the study's wrist-clearance limits, and meet the prosthetic-use experience requirement (≥5 years for Phases 1–2, ≥1 year for Phase 3) are ideal candidates.
✕Probably not a fit
Patients with open sores, heterotopic ossification, traumatic neuromas, or residual limb lengths outside the specified range are unlikely to be eligible or to benefit from this device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The project will design, custom-fit, and test a novel K-Socket-Harness (KSH) that uses hybrid polymer and textile materials inspired by advanced athletic shoe technology. Phase 1 will recruit five experienced Veteran end users to co-design the device and help develop a digital fitting system that maps residual limb shape and bony prominences. Phase 2 will involve iterative testing of fit, comfort, breathability, and functional use with refinements based on user and clinical feedback. A later phase will expand testing to compare user wear time and task performance against participants' existing prostheses.
Why it matters
Potential benefit: If successful, the KSH system could make prosthetic arms more comfortable and breathable, increasing wear time and functional use in daily activities.
How similar studies have gone: Previous attempts at breathable or porous liner technologies have had mixed results and this specific hybrid polymer-textile approach is relatively novel and not yet widely proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unilateral transradial arm amputation * Possession of a functioning and wearable previously fit prosthetic arm of any type * Residual limb length of at least 4 inches from the lateral epicondyle to the distal tip * Residual limb length less than or equal to that allowing a clearance of 1.5 inches from a fitted wrist * Must have at least 5-years of prosthetic use experience (For Phase 1 \& 2) * Must have at least 1-year of prosthetic use experience (For Phase 3 only) Exclusion Criteria: * Current open sores or incisions, Heterotopic ossification (HO), traumatic neuromas, or any other condition preventing the wearing of a prosthetic socket * Residual limb length less than 4 inches * Residual limb length greater than that allowing 1.5 inches clearance from a fitted wrist. The investigators will make every effort to recruit Veterans. If its found that it is not possible to recruit enough Veterans, the investigators will perform a non-Veteran amendment to this protocol.
Where it's running
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VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Rory A Cooper, PhD — VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
- Study coordinator: Elizabeth B Toth, BA
- Email: elizabeth.toth2@va.gov
- Phone: (412) 954-5382
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.