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

NCT06142669 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2024-01-22

No results posted yet for this 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.

Conditions

  • Joint Diseases

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.

Sponsors & Collaborators

  • MicroPort Orthopedics Inc.

    lead INDUSTRY

Principal Investigators

  • Pietro I Randelli, Prof · Gaetano Pini Orthopedic Institute

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2036-06-30
Completion
2036-12-31
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06142669 on ClinicalTrials.gov