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Clinical Trial Summary

This is a prospective, multicenter, observational study with a planned follow-up period of 10 years to confirm the safety and performance of the GEMINI SL Fixed Bearing PS knee prosthesis in longterm follow-up under routine conditions. Primary outcome of the study is the 10-year survival rate of the GEMINI SL Fixed Bearing PS knee prosthesis with revision for any reason as the endpoint.


Clinical Trial Description

The GEMINI SL Fixed Bearing PS knee prosthesis combines clinical proven design features with state-of-the-art-technology in order to achieve a high standard clinical performance, surgical efficiency and safety. Currently, no mid- and longterm clinical data are available for the GEMINI SL Fixed Bearing PS knee prosthesis. Therefore, the study is designed to generate clinical data of the GEMINI SL Fixed Bearing PS knee prosthesis in the 10-year follow-up under routine condition. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04858347
Study type Observational
Source Waldemar Link GmbH & Co. KG
Contact Kim Jacobs
Phone +49 (0)40 53995866
Email k.jacobs@link-ortho.com
Status Recruiting
Phase
Start date July 4, 2019
Completion date October 2035

See also
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