RecruitingNCT06142669

EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol

Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur With the EVOLUTION® MP CS Tibial Insert

Sponsor

MicroPort Orthopedics Inc.

Enrollment

45 participants

Start Date

Oct 31, 2023

Study Type

OBSERVATIONAL

Conditions

Joint Diseases

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

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert for people with joint diseases. The study is currently recruiting participants at 1 location. People eligible for this study include aged 21 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEVOLUTION® 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

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NCT06142669

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