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Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts
Sponsor: MicroPort Orthopedics Inc.
Summary
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.
Official title: Post Market Clinical Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2015-06-15
Completion Date
2028-12
Last Updated
2022-10-13
Healthy Volunteers
No
Conditions
Interventions
Total Knee Arthroplasty (EVOLUTION®)
Locations (5)
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
University Hospital Llandough
Penarth, South Glamorgan, United Kingdom