Evaluation of a knee revision implant system for joint diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety and effectiveness of the EVOLUTION® Revision Tibial System and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert in patients undergoing revision knee arthroplasty. The study will follow participants for up to 10 years to estimate the survivorship of the implant components and evaluate functional outcomes using various scoring systems. Additionally, it will monitor patient satisfaction and assess any adverse events related to the implants.

Why it matters

Who can join: the full rules

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

Where it's running

• Gaetano Pini Orthopedic Institute
  Milan, Piazza C. Ferrari 1 20122 Milan, Italy Recruiting

Study contacts

• Principal investigator: Pietro I Randelli, Prof — Gaetano Pini Orthopedic Institute
• Study coordinator: JoAnna-Marie N Becker, BS
• Email: joannamarie.becker@ortho.microport.com
• Phone: +1 901 290 5280

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.