LEGION™ Primary Total Knee System is CE-marked and marketed in all study regions. This study serves as post-market surveillance for LEGION™ Primary Total Knee System with the VERILAST™ bearing surface (OXINIUM™ femoral component with highly cross-linked polyethylene tibial insert). All study subjects will receive a LEGION™ Primary Total Knee System with VERILAST™ bearing surface and the results will be analysed against historical data from patients who received a Genesis II knee replacement.
The LEGION™ Primary Total Knee System (TKS) is a comprehensive, state-of-the-art system that empowers surgeons to address diverse surgical challenges and provide personalized joint care. The LEGION™ Primary TKS implant designs were built on the legacy of the GENESIS™ II TKS. For more than 15 years and in more than 30 countries, the GENESIS™ II TKS has achieved outstanding clinical outcomes. As CE-mark and 510k approval for the LEGION™ Primary TKS has been obtained, it is being used in clinical practice in several countries including Europe and the US but clinical studies need to be carried out in order to confirm its safety and efficacy and in order to conform to the medical device directives (MEDDEV. 2.7.1 Rev.3). This study is therefore a post-market study to evaluate the short-, mid- and long-term safety and effectiveness of the LEGION™ Primary TKS with VERILAST™ bearing surface (the combination of an OXINIUM™ femoral component with highly cross-linked polyethylene tibial base plate inserts). The clinical outcome from a large cohort of subjects who are treated with the LEGION™ Primary TKS as part of their standard of care will be documented. The study is designed to reflect standard clinical practice as closely as possible because it allows the results of such a study to represent the true clinical outcome that would be achieved in clinical practice, up to a maximum. Only subjects who will be treated with the LEGION™ Primary TKS as part of their normally planned care will screened for participation in this study.
Study Type
OBSERVATIONAL
Enrollment
163
All study subjects will be treated with LEGION™ Primary TKS with VERILAST™ Bearing Surface as per standard clinical practice.
Evangelisches Krankenhaus Wien
Vienna, Austria
Orthopadische Krankenhaus Gersthof
Vienna, Austria
AMEOS Klinikum Seepark Geestland
Langen, Kreis Geestland, Germany
OrthoCentrum
Hamburg, Germany
Survival
Non-inferiority of survival of Legion Primary with Verilast compared to a literature reference rate of 92.6% for Genesis II TKS
Time frame: 10 years
Number of revisions
Number of revisions (of any component of the device) at all follow up timepoints
Time frame: Discharge, 3 months, 1 year, 3 years, 5 years, 7 years, 10 years
Changes in mean 2011 Knee Society Score
Changes in mean 2011 Knee Society Score from baseline to each subsequent assessment
Time frame: Discharge, 3 months, 1 year, 3 years, 5 years, 10 years
Changes in mean Euroqol 5-D score
Changes in mean Euroqol 5-D score from baseline to each subsequent assessment
Time frame: Discharge, 3 months, 1 year, 3 years, 5 years, 10 years
Changes in radiographic evaluation
Changes in radiographic evaluation from baseline to each subsequent assessment
Time frame: Discharge, 3 months, 1 year, 3 years, 5 years, 10 years
AEs
Adverse Event reporting from surgery to 10 years post surgery
Time frame: Operative, Discharge, 3 months, 1 year, 3 years, 5 years, 7 years, 10 years
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CaritasKlinikum St. Joseph Saarbrücken-Dudweiler
Saarbrücken-Dudweiler, Germany
KniePraxis Prof. Dr. Tibesku
Straubing, Germany
Servicio de C.O.T. Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, Spain