Univation XM France
- Conditions
- Osteoarthritis, KneeUnicompartmental Knee ArthroplastyOsteoarthrosis of KneeArthritis Knee
- Registration Number
- NCT04199481
- Lead Sponsor
- Aesculap AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- Pregnancy
- Patient Age <18 years at the time of the surgery
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival Rate of the Implant 5 years after surgery Revision-free survival rate after 5 years according to Kaplan-Meier
- Secondary Outcome Measures
Name Time Method Development of Knee joint function in the postoperative course, up to 5 years after surgery Postoperative Development of knee joint function measured with the Knee Society Score (KSS). The KSS is composed of two subgroups "Knee Score" and "Function Score"; both parts have a maximum score of 100, where higher values represent better results.
Development of Oxford Knee Score in the postoperative course, up to 5 years after surgery A patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total knee replacement (TKR) arthroplasty. Oxford Knee Score has a maximum of 48 points indicating satisfactory knee function
Intraoperative/surgery Data intraoperative Surgical and intraoperative data collected will include the date and duration of the surgery, selected implants and sizes, blood loss and implant descriptions. Surgical duration is to be measured from the time of incision to the time of skin closure, skin-to-skin. All potential Adverse Events will be collected during the surgical procedure and/or from the surgical record and will be documented on the intra-operative Evaluation Form.
Radiographic evaluation in the postoperative course, up to 5 years after surgery The outcome and function of a knee prosthesis is influenced by the postoperative alignment of the leg and the orientation in reference to the axis. Incorrect positioning can lead to an increased implant wear and functional limitations; The aim of a postoperative alignment within 3° varus to 3° valgus will be assessed using long leg x-rays up to 5 years after surgery
Rate of Serious Adverse Events in the postoperative course, up to 5 years after surgery As part of the follow-up examination, any upcoming (serious) adverse device events or effects related or not related to the product under investigation, will be documented in the dedicated Case Report Forms. Recorded complications will be categorized and analyzed in order to assess the safety of the univation XM prosthesis
Trial Locations
- Locations (1)
CHU Hopital Hautepierre
🇫🇷Strasbourg, France