MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.
MicroPort Orthopedics Inc. (MPO) currently markets the EVOLUTION® TKA System globally, including in the European Union (EU). As part of the process for gaining approval to market in the EU, MicroPort is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of this system. These types of studies are required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. The objectives of this study are to evaluate component survivorship, cumulative revision rate, functional outcome scores, and subject satisfaction at early, midterm, and long-term follow-up.
Study Type
OBSERVATIONAL
Enrollment
150
Illinois Bone & Joint Institute
Morton Grove, Illinois, United States
AZ Maria-Middelares
Ghent, Belgium
The Ottawa Hospital
Ottawa, Ontario, Canada
Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie, St. Marien Hospital Mülheim an der Ruhr
Mülheim, Germany
Component Survivorship
The primary endpoints are analysis of survivorship for all components at each follow-up interval out to 10 years
Time frame: 10 years post-operative
Patient functional outcomes scores (assessed by KOOS Scores and EQ-5D-3L Scores)
To characterize functional scores for subjects, as assessed by KOOS Scores and EQ-5D-3L Scores
Time frame: 2-<5 years, 5-7 years, and 10 years
Cumulative Revision Rate
To determine the cumulative revision rate at specified intervals out to 10 years follow-up
Time frame: 2-<5 years, 5-7 years, and 10 years
Subject Satisfaction (assessed by Patient Satisfaction Questionnaires)
To assess subject satisfaction with their TKA procedure
Time frame: 2-<5 years, 5-7 years, and 10 years
Number of Radiolucencies
To summarize the number of radiolucencies in zones surrounding implanted components
Time frame: 2-<5 years, 5-7 years, and 10 years
Size of Radiolucencies
To summarize the size of radiolucencies in zones surrounding implanted components
Time frame: 2-<5 years, 5-7 years, and 10 years
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University Hospital Llandough
Penarth, South Glamorgan, United Kingdom