Wear, bone density, functional outcome and survival of vitamin E incorporated polyethylene cups in reversed hybrid total hip arthroplasty: a randomized controlled trial
Recruiting
- Conditions
- degenerative hip joint diseaseosteoarthritis of the hip1002321310005944
- Registration Number
- NL-OMON53149
- Lead Sponsor
- Martini Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
1. Primary osteoarthritis of the hip
2. Age < 70 years
Exclusion Criteria
1. Secondary osteoarthritis of the hip
2. (Active) arthritis (eg rheumatic disease)
3. Peripheral neuropathy
4. History of CVA
5. Cognitive impairments (eg dementia)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to compare polyethylene wear (mm/year) at 10 years<br /><br>between the 2 groups.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters are:<br /><br>1. polyethylene wear (mm/year) at 1 and 3 years postoperatively<br /><br>2. relative decrease/increase in acetabular BMD at 1 and 2 years postoperatively<br /><br>3. acetabular and proximal femoral osteolytic changes at 1, 3 and 10 years<br /><br>postoperatively.<br /><br>4. patient-reported (Oxford Hip Score) and physician-reported (Harris Hip<br /><br>Score) functional outcome at 6 weeks and 1, 3, 5, 7 and 10 years<br /><br>postoperatively.<br /><br>5. quality of life (SF-36) and physical activity behaviour (SQUASH) at 1, 3, 5,<br /><br>7 and 10 years postoperatively.<br /><br>6. survival (number of revisions) determined at 5 and 10 years postoperatively.</p><br>