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| Sponsors and Collaborators: |
Lovisenberg Diakonale Hospital Helse Sør-Øst Biomet, Inc. Ullevaal University Hospital |
|---|---|
| Information provided by: | Lovisenberg Diakonale Hospital |
| ClinicalTrials.gov Identifier: | NCT00804388 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Primary Arthrosis Degenerative Joint Disease |
Procedure: Total hip arthroplasty |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Comparing Polyethylene Wear Using 3. Generation Highly Crosslinked Polyetylene in an Uncemented Total Hip Prostheses With Either 32 mm or 36 mm Caput of Ceramics |
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Uncemented total hip replacement, 32 mm caput
|
Procedure: Total hip arthroplasty
32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene
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|
2: Active Comparator
Uncemented total hip replacement, 36 mm caput
|
Procedure: Total hip arthroplasty
32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene
|
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.
Eligibility| Ages Eligible for Study: | 50 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Einar Lindalen, MD | +47 23 22 50 00 | eli@lds.no |
| Contact: Stephan M. Røhrl, MD, PhD | +47 22 11 80 80 | s.m.rohrl@medisin.uio.no |
| Norway | |
| Lovisenberg Diakonale sykehus | Recruiting |
| Oslo, Norway | |
| Contact: Einar Lindalen, MD +47 23 22 50 00 eli@lds.no | |
| Contact: Stephan M. Røhrl, MD,PhD +47 22 11 80 80 s.m.rohrl@medisin.uio.no | |
| Principal Investigator: Einar Lindalen, MD | |
| Study Chair: | Stephan M. Røhrl, MD,PhD | Ullevål Univeristy Hospital Norway |
| Study Chair: | Einar Lindalen, MD | Lovisenberg Diakonale sykehus |
More Information
| Responsible Party: | Lovisenberg Diakonale sykehus ( Einar Lindalen, MD, Lovisenberg Diakonale sykehus ) |
| Study ID Numbers: | S-08366a, 03-2008 LDS |
| Study First Received: | December 5, 2008 |
| Last Updated: | December 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00804388 History of Changes |
| Health Authority: | Norway: The National Committees for Research Ethics in Norway; Norway: Directorate for Health and Social Affairs; Norway: Data Inspectorate |
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Vitamine E E-poly Hip Degenerative joint disease |
|
Tocopherol acetate Antioxidants Osteoarthritis Joint Diseases Trace Elements Rheumatic Diseases Alpha-Tocopherol |
Tocopherols Vitamin E Musculoskeletal Diseases Arthritis Vitamins Tocotrienols Micronutrients |
|
Antioxidants Molecular Mechanisms of Pharmacological Action Osteoarthritis Growth Substances Joint Diseases Physiological Effects of Drugs Rheumatic Diseases Protective Agents |
Pharmacologic Actions Tocopherols Vitamin E Musculoskeletal Diseases Arthritis Vitamins Micronutrients |
