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The study will determine the survivorship of the fixed bearing P.F.C. Sigma knee with a cobalt chrome tibial tray at 5 years.
The primary objective of this study is to assess the survivorship of the P.F.C. fixed bearing knee system using a cobalt chrome tibial tray and moderately cross-linked polyethylene insert at 5-Years. The secondary objectives of this investigation are to evaluate additional clinical outcomes to provide further information on the performance of the P.F.C. fixed bearing knee system using a moderately cross-linked polyethylene insert and cobalt chrome tibial tray. These outcomes will include Radiographic assessment, American Knee Society Score, Oxford Knee Score and SF-12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P.F.C. Sigma Knee System | Orthopaedic implant for primary total knee replacement with a cobalt-chrome tibial tray and a moderately cross-linked polyethylene tibial insert |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P.F.C. Sigma Knee | Device | Orthopaedic implant for primary total knee replacement with a cobalt-chrome tibial tray and a moderately cross-linked polyethylene tibial insert |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is a survivorship analysis of the P.F.C. fixed bearing knee system with a cobalt chrome tibial tray and moderately cross linked polyethylene insert at the five-year time point. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from pre-operative assessment Clinical outcome and patient-derived outcome in terms of joint-specific quality of life. | 3 month, 1,3, 5 and 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asklepios Klinic/ Lindenlohe Orthopeadic Hospital | Schwandorf in Bayern | Deutschland | Germany | |||
| Hospital S Antonìo Of Padova |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Padova |
| Italy |
| Princess Alexandra Hospital | Harlow | Essex | CM20 1QX | United Kingdom |
| Queen Margaret Hospital | Dunfermline | Fife | KY12 0SU | United Kingdom |
| Arrowe Park Hospital | The Wirral | Merseyside | CH49 5PE | United Kingdom |
| D012216 |
| Rheumatic Diseases |