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Completed
NCT04787640
Wear and Tear Evaluation of New Nike Sport Sole for Runnnig Prosthesis
Conditions: Lower Limb Amputation Below Knee (Injury)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 3
Sponsor: Össur Iceland ehf
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.
Eligibility Criteria
Inclusion Criteria:
* 50Kg\< body weight \< 116Kg
* K-level: K3 and K4
* Amputation level: Unilateral, bilateral, Trans-tibial, trans-femoral
* Currently using running prosthesis with the option to connect to the components the investigational device is compatible to
* Minimum build height: Distance from ground to socket adapter needs to be 318 mm or more.
* Comfortable and stable socket fit
* Willing and able to participate in the study and follow the protocol
Exclusion Criteria:
* 50Kg\> body weight \> 116Kg
* Users with socket problems
* Users with cognitive impairment
* Younger than 18 years old
Source: ClinicalTrials.gov (NCT04787640). StuddyBuddy aggregates publicly available trial information.