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Recruiting Observational

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

NCT06142669 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2023-10-31
Last updated
2024-01-22

Condition(s) studied

Joint Diseases

Investigational drug(s) / intervention(s)

EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert

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

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires implantation of the components under study (EVOLUTION® Revision Tibial System and EVOLUTION® STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert) 2. Decision to perform the study index surgery with the required study components is pre-determined regardless of the research; 3. Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their study index surgery 4. Willing to voluntarily sign the informed consent form 5. Willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit. Exclusion Criteria: 1. Skeletally immature (less than 21 years of age) at time of implantation 2. Has or had an overt infection at the time of implantation 3. Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable 4. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol 5. Has or had documented substance abuse issues 6. Has or had an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study 7. Currently incarcerated or has impending incarceration 8. Has a medical condition, as judged by the Investigator, that would interfere with the subject's ability to comply with the requirements of the protocol

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)

FacilityCityRegionStatus
Gaetano Pini Orthopedic Institute Milan Piazza C. Ferrari 1 20122 Milan Recruiting

Other trials for the same condition

Official registry record

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