Patient Blinded Randomized Clinical Trial comparing two types of mobile bearing unicondylar knee replacement
Completed
- Conditions
- OsteoarthritisWorn knee10005944
- Registration Number
- NL-OMON40703
- Lead Sponsor
- Slotervaartziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 236
Inclusion Criteria
• Age > 18
• BMI < 40
• Medial Unicondylar symptomatic OA of a knee joint
• Able to provide informed consent
Exclusion Criteria
• Co-morbidity influencing the outcome of the implant.
• Hypersensetivity to metals.
• Not being able to fill in the Dutch Questionnaires.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Our main study endpoint is the Oxford Knee Score. A knee specific questionnaire<br /><br>specifically designed to measure outcome in knee arthroplasty patients. This<br /><br>score was chosen since most Partial Knee studies use this outcome, therefore<br /><br>our study can be compared with the other Partial Knee papers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• To compare the overall QoL in patients with a Single Radius design<br /><br>Unicondylar knee implant (Oxford Partial Knee ®) to patients with a Multi<br /><br>Radius design (ACS® unicondylar). The Quality of life will be measured by using<br /><br>standardized questionnaires being: NRS for pain, EQ5D and a KOOS-PS.<br /><br>• To monitor and compare the revisions (survival) rate of both groups. All<br /><br>revisions (septic and aseptic) and second surgery for other reasons will be<br /><br>included in the survival analysis.<br /><br>• Level of resection needed for implantation. </p><br>