NCT04199481

Univation XM France

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee
• Osteoarthrosis of Knee
• Arthritis Knee
• Unicompartmental Knee Arthroplasty

Timeline

• Start date: 2020-08-01
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2019-12-16
• Last updated: 2020-07-23

Locations

1 site across 1 country: France