Recruiting

KSH System

Sponsor:

VA Office of Research and Development

Code:

NCT05990062

Conditions

Amputation, Surgical

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

K-Socket-Harness

Study Details

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 standard hard sockets and rubber liners with a hybrid polymer and textile-based design derived from advanced athletic shoe technology. The project consists of designing, custom fitting and evaluating the function and comfort of the this new novel system. The study will take place in 3 phases; Phase 1, five experienced Veterans with transradial arm amputations will be recruited to provide guidance and to assist with the design and development. Experienced end-user Veterans and Clinical staff will work together to assist with design, develop the fitting process and working with engineers on the design of a completely digital fitting device for measuring the residual limb and locating bony prominences of the limb to inform the socket design. Phase 2, testing and assessment, the design and process validation will take place with the five Veteran upper transradial arm amputees Phase 3, an additional 20 Veterans with transradial arm amputations will be recruited and fit with the KSH system and undergo a series of evaluative tests. Veterans will perform a series of static and dynamic tasks to evaluate function, comfort and load bearing failure. The primary goal of this study is to improve upon the current preliminary prototype and to test it with a broader population of potential users to help advance the engineering and design, and to learn the potential to fit a range of Veterans with transradial amputations.

Conditions

Amputation, Surgical

Study ID

NCT05990062

Start date

Jun 1, 2025

Status verified date

Jul, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Verify performance gains for the innovative KSH system that can be delivered to Veterans. The new de

The investigators will perform several functional tests of the both the KSH system and the standard of care prosthesis: tensile static load bearing capacity before failure, test rowing ergometer 10-minute test before failure measured using strokes per minute, power in Watts, distance in meters, maximal force, and time before failure, range of motion in flexion/extension, and donning/doffing time.

experimental: Verify functionality of the KSH system through testing with end-users.

The investigators will use System Usability Scale (SUS) to assess high usability with setup and operation of the device. The investigators will assess Comfort Scores (SCS), evaluate weight and correlate it with user satisfaction. The investigators will report selection outcome between new design and current design. The investigators will asses 1) functional status, (2) health- related quality of life, and (3) satisfaction with services and (4) device scores through the Orthotics and Prosthetics User Survey (OPUS).

Interventions

K-Socket-Harness

A transradial socket and harness design that offers a hybrid polymer and textile-based design derived from advanced athletic shoe technology. The KSH integrated socket, frame, and wrist, the "variable compliance prosthetic socket with breathable matrix," creates a dynamic and secure attachment with a combination of two lacing systems. The lacing systems lengthen and shorten six flexible hinges at the elbow, maintaining a secure attachment throughout the range of motion and accounting for volume changes in the soft tissue of the elbow that would otherwise restrict range of motion or cause the socket to separate from the residual limb.

Primary outcome measure

  • Static tensile load bearing capacity to reach a 50-pound load on an industrial scale [ Time Frame: 20 minutes ]
  • Elbow range of motion in flexion/extension [ Time Frame: 30 minutes ]
  • Donning/doffing prosthesis [ Time Frame: 30 minutes ]
  • Power in Watts generated on rowing machine [ Time Frame: 10 minutes ]
  • Strokes per 10-minute period [ Time Frame: 10 minutes ]
  • Distance rowed in meters [ Time Frame: 10 minutes ]
  • Maximal force before failure [ Time Frame: 10 minutes ]
  • Total time before failure [ Time Frame: 10 minutes ]

Central Contacts and Locations

Central contacts

Elizabeth B Toth, BA

(412) 954-5382elizabeth.toth2@va.gov

Locations

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Recruiting

Pittsburgh, Pennsylvania, United States, 15240

Contacts

Elizabeth B Toth, BA

(412) 954-5382elizabeth.toth2@va.gov

Principal Investigator:

Rory A Cooper, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • function
  • breathability
  • comfort
  • transradial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-07-24.