Univation XM France

Aesculap

Status: Withdrawn

Conditions: Unicompartmental Knee Arthroplasty; Arthritis Knee; Osteoarthrosis of Knee; Osteoarthritis, Knee

Study type: Observational

Funder types: Industry

Identifiers

NCT04199481

AAG-O-H-1822

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has received a primary mobile bearing UKA at the study site between January 2017 and December 2018 using the product under investigation
• Patient's written consent and willingness to participate at the clinical study and the follow-up examinations

Exclusion criteria

• Pregnancy
• Patient Age <18 years at the time of the surgery