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| Name | Class |
|---|---|
| Stryker Nordic | INDUSTRY |
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Polyethylene wear debris from metal-on-polyethylene articulations are one of the main causes of periprosthetic bone loss and non-infectious loosening in total hip arthroplasty. Ceramic articulations have a very low wear rate when measured in the laboratory and the investigator's hypothesis is that hip arthroplasty with an all ceramic articulation will have less osteolysis and wear in addition to equally good fixation and clinical outcome compared to the same hip arthroplasty design with a metal-on-polyethylene joint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metal-on-conventional polyethylene | Active Comparator | Uncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a CoCr prosthetic femoral head and an acetabular liner made of intermedially cross-linked polyethylene polyethylene (Duration, Stryker, Mahwah, NJ, US). |
|
| Ceramic-on-ceramic | Experimental | Uncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a prosthetic femoral head and an acetabular liner made of alumina ceramic (Biolox Forte, Ceramtec, Plochingen, Germany). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceramic-on-ceramic uncemented hip arthroplasty | Device |
| ||
| Metal-on-polyethylene uncemented total hip arthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Osteolysis frequency change between 7 and 15 years | Osteolysis frequency (%) measured with computed tomography, | Change between 7 to 15 years after surgery |
| Osteolysis size change between 7 and 15 years | Osteolysis size (cm3) measured with computed tomography | Change between 7 and 15 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Articulation wear at 7 years | Articulation wear as measured with radiostereometry, mm/year | At 7 years after surgery |
| Articulation wear at 15 years | Articulation wear as measured with radiostereometry, mm/year |
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Inclusion Criteria:
Exclusion Criteria:
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Prospective randomized study
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| Device |
|
| 15 years after surgery |
| Implant fixation at 7 years | Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry | 7 years after surgery |
| Implant fixation at 15 years | Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry | At 15 years after surgery |
| Clinical function at 7 years | Harris Hip Score (0-100) | 7 years after surgery |
| Clinical function at 15 years | Harris Hip Score (0-100) | 15 years after surgery |
| ID | Term |
|---|---|
| D010014 | Osteolysis |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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