Status:
RECRUITING
Improving Prosthetic Arms for Amputee: A Better Fit and More Functionality
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Stumpworx LLC
Conditions:
Amputation, Surgical
Eligibility:
All Genders
Phase:
NA
Brief Summary
This research and development will improve upon and investigate the potential validity of an innovative new transradial socket and harness design (the KSH system) that offers an alternative to standar...
Detailed Description
Acceptance of prosthetic arms has long been a problem for clinical prosthetics, and recent studies indicate that recent advancements have done little to improve usage. Objections related to the fit an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05990062
Start Date
June 1 2025
End Date
September 30 2028
Last Update
June 26 2025
Active Locations (1)
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1
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240