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EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol
Sponsor: MicroPort Orthopedics Inc.
Summary
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® Revision Tibial System and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.
Official title: Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur With the EVOLUTION® MP CS Tibial Insert
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
OBSERVATIONAL
Enrollment
45
Start Date
2023-10-31
Completion Date
2036-12
Last Updated
2024-01-22
Healthy Volunteers
No
Conditions
Interventions
EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert
Primary knee arthroplasty or a revision knee that requires a revision procedure.
Locations (1)
Gaetano Pini Orthopedic Institute
Milan, Piazza C. Ferrari 1 20122 Milan, Italy