Osteoarthritis, Knee Clinical Trial
Official title:
A Prospective, Observational, Monocentre 5-year Follow-up Clinical Trial on a Historical Consecutive Cohort of Unicompartmental Knee Arthroplasty Patients Treated With the Mobile Bearing Unicondylar Knee Prosthesis Univation XM
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.
n/a
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