Study Stopped
Study stopped due to product discontinuation by manufacturer
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
1 other identifier
observational
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2020
Typical duration for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2019
CompletedFirst Posted
Study publicly available on registry
December 16, 2019
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedJuly 23, 2020
July 1, 2020
3 years
December 12, 2019
July 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival Rate of the Implant
Revision-free survival rate after 5 years according to Kaplan-Meier
5 years after surgery
Secondary Outcomes (5)
Development of Knee joint function
in the postoperative course, up to 5 years after surgery
Development of Oxford Knee Score
in the postoperative course, up to 5 years after surgery
Intraoperative/surgery Data
intraoperative
Radiographic evaluation
in the postoperative course, up to 5 years after surgery
Rate of Serious Adverse Events
in the postoperative course, up to 5 years after surgery
Eligibility Criteria
adult patients
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Patient Age \<18 years at the time of the surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aesculap AGlead
- B. Braun Medical SAcollaborator
Study Sites (1)
CHU Hopital Hautepierre
Strasbourg, 67098, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2019
First Posted
December 16, 2019
Study Start
August 1, 2020
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
July 23, 2020
Record last verified: 2020-07