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Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur
Sponsor: MicroPort Orthopedics Inc.
Summary
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION® CS tibial inserts. 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® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur With Cruciate Sacrificing Inserts
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2020-02-03
Completion Date
2032-08
Last Updated
2024-03-20
Healthy Volunteers
No
Conditions
Interventions
Primary Knee implants
Primary knee arthroplasty
Locations (1)
Covenant Medical Center
Saginaw, Michigan, United States