WEAR, BONE DENSITY, FUNCTIONAL OUTCOME AND SURVIVAL IN VITAMIN E INCORPORATED CUPS IN TOTAL HIP ARTHROPLASTY: A RANDOMIZED CONTROLLED TRIAL.
- Conditions
- Total Hip Arthroplasty, Vitamin E, polyethylene, wear
- Registration Number
- NL-OMON22433
- Lead Sponsor
- Martini Hospital, Department of Orthopaedic Surgery; University Medical Center Groningen (UMCG), Department of Orthopaedic Surgery
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
1. Patients with non-inflammatory degenerative joint disease of the hip, scheduled for a primary unilateral total hip arthroplasty;
2. Age < 70 years.
Exclusion Criteria
1. Secondary osteoarthritis of the hip;
2. (Active) arthritis (eg rheumatic disease);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Polyethylene wear (mm/y) at 10 years postoperatively.
- Secondary Outcome Measures
Name Time Method 1. Polyethylene wear at 1, 3, 5 and 7 years postoperatively;<br /><br>2. Relative decrease/increase in acetabular bone mineral density (BMD) at 1 and 2 years postoperatively;<br /><br>3. Acetabular and proximal femoral osteolytic changes at 1, 3, 5, 7 and 10 years postoperatively;<br /><br>4. Patient-reported functional outcome, health related quality of life and physical activity (HOOS) and physician-reported functional outcome (Harris Hip Score) at 6 weeks and 1, 3, 5, 7 and 10 years postoperatively;<br /><br>5. Physical activity behaviour (SQUASH) at 1, 3, 5 and 10 years postoperatively;<br /><br>6. Survival (number of revisions) determined at 5 and 10 years postoperatively.