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| Name | Class |
|---|---|
| Biomet Merck Aps,Horsens, Denmark | UNKNOWN |
| Gigtforeningen | OTHER |
| Sahva A/S, Borgervænget 5-7, København Ø, Denmark | UNKNOWN |
| Danske Fysioterapeuter |
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The purpose of this study is to compare two total hip replacement systems: Hip Resurfacing System (ReCap) versus Mallory-Head/Exeter.
In Denmark approximately 7000 primary hip replacements are implanted yearly, and the incidence is rising with the increasingly aging population. For older patients, the incidence of later revisions of hip implantation is low. Unfortunately, this is not true for younger patients. Approximately 20% of patients under 55 years of age at the time of surgery must have the hip implant renewed within 10 years.
This is primarily because of the wear generated by polyethylene debris. The polyethylene is associated with osteolysis in the proximity of the prosthesis leading to failure of the prosthesis.
This unsatisfactory result has led to the development of an alternative hip prosthesis especially to benefit younger and physically active people. The new prosthesis should produce less inflammatory debris and less osteolysis induced failure.
To avoid the polyethylene particles, a new type of prosthesis has been made articulating metal on metal. The Hip Resurfacing System consists of an alloy of chrome - cobalt - molybdenum. Another point of interest for this prosthesis is also the size of the articulating surfaces which are bigger than usual. This will theoretically participate in the generation of metal ions.
Study objectives:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReCap, Hip resurfacing system, Biomet | Device | ReCap total hip arthroplasty inserted according to manufactures manual. |
| Measure | Description | Time Frame |
|---|---|---|
| Metal ion release evaluated in urine | three years | |
| Gait pattern evaluated with 3D gait analysis, Vicon Polygon | two years | |
| Bone mineral density (BMD) in surrounding bone of the prosthesis | three years | |
| Prostheses migration evaluated by radiostereometric analysis (RSA) | three years | |
| Proinflammatory- and bone degradation measures in blood samples | three years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kjeld Søballe, MD., Prof. | Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Center, Aarhus University Hospital | Aarhus | Jylland | 8000 | Denmark |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| OTHER |
| Regionshospitalet Silkeborg | OTHER |
| Finnish Institute of Occupational Health | OTHER |
| Regionshospitalet Hammel Neurocenter | OTHER |
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