Clinical Trial

Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur

Active, Not Recruiting
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-03-06; most recent amendment 2024-03-19.
Status change: Recruiting → Active, Not Recruiting 2022-03-18
Trial Details
NCT Number NCT04301622
Lead Sponsor MicroPort Orthopedics Inc.
Conditions Knee Osteoarthritis, Traumatic Arthritis of Knee, Avascular Necrosis, Degenerative Joint Disease of Knee, Rheumatoid Arthritis of Knee, Correction of Functional Deformity
Enrollment 150 participants
Start Date 2020-02-03
Primary Completion 2032-02 (estimated)
Study Completion 2032-08 (estimated)
Updated on ClinicalTrials.gov 2024-03-20