Wear Measurements of E-Poly in an Uncemented THA With Either 32 or 36 mm Caput of Ceramics.
This trial is active, not recruiting.
|Conditions||primary arthrosis, osteoarthritis|
|Treatment||total hip arthroplasty|
|Sponsor||Lovisenberg Diakonale Hospital|
|Start date||December 2008|
|End date||February 2012|
|Trial size||50 participants|
|Trial identifier||NCT00804388, 03-2008 LDS, S-08366a|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Measure polyethylene wear and bone mineral density between the two groups
time frame: 2 year
Male or female participants from 50 years up to 65 years old.
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
|Official title||Comparing Polyethylene Wear Using 3. Generation Highly Crosslinked Polyethylene in an Uncemented Total Hip Prostheses With Either 32 mm or 36 mm Caput of Ceramics|
|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.|
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