Wear rate of a Highly Cross-Linked polyethylene stabilized with vitamin E in Total Hip Arthroplasty.;A Randomized Controlled Trial
Withdrawn
- Conditions
- coxarthosiship arthrosis1002321310005944
- Registration Number
- NL-OMON34827
- Lead Sponsor
- Diakonessenhuis Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
All patients scheduled for a total hip arthroplasty. Inclusion criterion, patients diagnosed for coxarthrosis, dysplastic coxarthrosis, rheumatoid arthritis , necrosis of the head of the femur or posttraumatic coxarthrosis. Patients between 20 and 75 years old at the time of inclusion.
Exclusion Criteria
Exclusion criteria; patients designated for revision surgery, suffer from sepsis, malignant tumours, severe diabetes mellitus, severe cardiovascular diseases (ASA>II)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary final study point is the polyethylene wear rates. Measuring is<br /><br>based on anterior-posterior (AP) radiographs at 3,12 and 24 months using a<br /><br>computer-assisted edge-detection system (ROGAN Delft, VPX ortho)<br /><br>The software calculates femoral head displacement (mm) and the angle (°) as a<br /><br>representation of wear. </p><br>
- Secondary Outcome Measures
Name Time Method