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RECRUITING
NCT06142669

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

Sponsor: MicroPort Orthopedics Inc.

View on ClinicalTrials.gov

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

DEVICE

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