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.
Study Type
OBSERVATIONAL
Enrollment
650
Orthopaedic implant for primary total knee replacement with a cobalt-chrome tibial tray and a moderately cross-linked polyethylene tibial insert
Asklepios Klinic/ Lindenlohe Orthopeadic Hospital
Schwandorf in Bayern, Deutschland, Germany
Hospital S Antonìo Of Padova
Padova, Italy
Princess Alexandra Hospital
Harlow, Essex, United Kingdom
Queen Margaret Hospital
Dunfermline, Fife, United Kingdom
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.
Time frame: 5 years
Changes from pre-operative assessment Clinical outcome and patient-derived outcome in terms of joint-specific quality of life.
Time frame: 3 month, 1,3, 5 and 10 years
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Arrowe Park Hospital
The Wirral, Merseyside, United Kingdom