EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- The proportion of EVOLUTION® Revision Tibial Base components survivorship out to 10 years. — up to 10 years
Percentage of knees survived with no revision or replacement at 10-year - The proportion of EVOLUTION® STEMMED CS Femoral components survivorship out to 10 years. — up to 10 years
Percentage of knees survived with no revision or replacement at 10-year - The proportion of EVOLUTION® MP CS tibial inserts survivorship out to 10 years. — up to 10 years
Percentage of knees survived with no revision or replacement at 10-year
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Gaetano Pini Orthopedic Institute | Milan | Piazza C. Ferrari 1 20122 Milan | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06142669 on ClinicalTrials.gov ↗ ← All trials in Italy