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Prospective, monocenter post market clinical follow-up of a primary knee replacement bearing the CE-mark.
200 subjects will be recruited and followed up for up to ten years or until revision of the primary knee endoprosthesis, whichever occurs first. Documentation of clinical and radiological parameters within the clinical routine pre-operative and post-operative at 3 and 12 months and 2, 5 and 10 years to evaluate time to revision, pain situation, knee functionality, mobility and stability.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPK-S Integration | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Time until revision | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of clinical situation based on Knee Society Score | 3 and 12 months, 2, 5, 10 years | |
| Documentation of incidents | Up to 10 Years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing primary total knee endoprosthesis with BPK-S Integration of age 18 and older
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landesklinikum Amstetten | Amstetten | Lower Austria | 3300 | Austria |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007593 | Joint Instability |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| D012216 |
| Rheumatic Diseases |