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Clinical Trial Summary

The study is set up due to regulatory purposes and to collect routine clinical data of the mobile-bearing implant univation XM. The study is designed as a prospective follow-up study with a historic patient cohort who have been treated with the product under investigation two years ago. This design is selected to quicker realize follow-up data as patients have already been treated in the past.

As the mobile version of the implant is not widely used, the study will be set up as a monocentric study in France. The clinical hypothesis of the study is that patients who are treated with the product under investigation have a similar outcome and survival rate in comparison to other established unicondylar knee systems on the market. Comparison for the later evaluation will be taken out of recent orthopaedic registries.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04199481
Study type Observational
Source Aesculap AG
Contact
Status Withdrawn
Phase
Start date August 2020
Completion date August 2023

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