Wear Measurements of E-Poly in an Uncemented THA With Either 32 or 36 mm Caput of Ceramics.
Not Applicable
- Conditions
- Primary ArthrosisOsteoarthritis
- Registration Number
- NCT00804388
- Lead Sponsor
- Lovisenberg Diakonale Hospital
- Brief Summary
The aim of the study is to compare polyethylene wear in an uncemented total hip prosthesis with 3rd. generation highly cross-linked polyethylene with a 32 mm ceramic femoral head compared to a 36 mm ceramic head. Using X-ray, RSA and DEXA.
The polyethylene to be used is E-Poly (Biomet).
The H0 hypothesis is that there is no difference with regard to polyethylene wear and bone loss between the two groups.
- Detailed Description
Uncemented THA, 32 mm or 36 mm caput of ceramics, E-Poly inserts. Measure wear with RSA, X-Ray and bone mineral density with DEXA.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- 50-65 years old
- Primary or secondary osteoarthritis
Exclusion Criteria
- Significant anatomical divergence are excluded
- Rheumatoid arthritis
- Fracture sequelae
- Dysplasia
- Immune suppression or grave systemic illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Measure polyethylene wear and bone mineral density between the two groups 2 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Lovisenberg Diakonale sykehus
🇳🇴Oslo, Norway
Lovisenberg Diakonale sykehus🇳🇴Oslo, Norway