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Univation XM France

NCT04199481 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2020-07-23

No results posted yet for this study

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

Sponsors & Collaborators

  • B. Braun Medical SA

    collaborator INDUSTRY

  • Aesculap AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04199481 on ClinicalTrials.gov