Osteoarthrosis Clinical Trial
Official title:
A Comparison of Two Total Hip Replacements: Hip Resurfacing System Versus Mallory-Head/Exeter
The purpose of this study is to compare two total hip replacement systems: Hip Resurfacing System (ReCap) versus Mallory-Head/Exeter.
Status | Completed |
Enrollment | 50 |
Est. completion date | January 2012 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patient with primary hip osteoarthrosis (OA). - Informed patient consent in writing. - Sufficient bone density to allow uncemented implantation of an acetabular component. Exclusion Criteria: - Presence of other metal implants. - Working exposure of chrome, cobalt or molybdenum. - Ingestion of multivitamin or medication containing chrome, cobalt or molybdenum. - Kidney disease - Hip joint dysplasia - Patients with neuromuscular or vascular disease in the affected leg. - Patients who regularly take non-steroid anti-inflammatory drugs (NSAID) and cannot interrupt intake for the postoperative phase of the study. - Patients with fracture sequelae. - Female patients of childbearing capacity. - Sequelae to previous hip joint disorder in childhood |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Orthopaedic Center, Aarhus University Hospital | Aarhus | Jylland |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Biomet Merck Aps,Horsens, Denmark, Danske Fysioterapeuter,Nørre Voldgade 90, København, Denmark, Finnish Institute of Occupational Health, Gigtforeningen,Gentoftegade 118, Gentofte, Denmark, Regionshospitalet Hammel Neurocenter, Regionshospitalet Silkeborg, Sahva A/S, Borgervænget 5-7, København Ø, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Metal ion release evaluated in urine | three years | No | |
Primary | Gait pattern evaluated with 3D gait analysis, Vicon Polygon | two years | No | |
Primary | Bone mineral density (BMD) in surrounding bone of the prosthesis | three years | No | |
Primary | Prostheses migration evaluated by radiostereometric analysis (RSA) | three years | No | |
Primary | Proinflammatory- and bone degradation measures in blood samples | three years | No |
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