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NCT04787640

Wear and Tear Evaluation of New Nike Sport Sole for Runnnig Prosthesis

Sponsor: Össur Iceland ehf

View on ClinicalTrials.gov

Summary

Running Specific Feet are based on the original Flex-Foot design using the energy storage and release function as the main design feature. Running specific prosthetic feet are intended for running and jogging. They all have similar design features such as a C-shaped spring carbon fiber foot plate that absorbs and returns energy when load is applied deflecting the carbon. In order to accommodate the running pattern which does not show a double stance phase as compared to walking, the Running Specific products do not feature a heel spring but directly load the C-shape spring at initial contact. The Running Specific Feet are usually equipped with additional accessory parts such as a traction sole or spike pad for smoother and more natural rollover. The investigational device, the Nike Sport Sole, is an accessory for the Cheetah Xceed running prosthetic foot. Cheetah Xceed has already been placed on market and bears a CE mark, but the Nike Sport Sole is an upgraded Nike Sole design and the objective of this clinical investigation is to evaluate the observed wear and tear of the soles after 6-8 week usage among other usability aspects.

Official title: Wear and Tear Evaluation of New Nike Sport Sole, an Accessory Attachable and Detachable to the Running Prosthesis Cheetah Xceed

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2020-02-20

Completion Date

2021-02-03

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

DEVICE

Nike Sport Sole

The Nike Sport Sole comes in two different versions, Nike traction sole and Nike spike pad. Both versions are easily attachable and detachable to the foot blade of the running specific prosthetic foot, Cheetah® Xceed. Both sole versions consist of a rubber traction sole with a soft foam core. The Nike spike pad consists of a spike sole with a soft foam core and should be used when running on tartan track. Both sole versions are attached in the same way to the carbon foot blade. The devices slide onto the carbon foot blade and are connected by pulling a strap of the sole over an attachment piece (medallion) that is connected to the foot blade. Additionally, there are attachment clips on the side clamp on the foot blade.