Evaluation of a knee revision implant system for joint diseases
Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur With the EVOLUTION® MP CS Tibial Insert
This study is testing a new knee implant system to see how safe and effective it is for people getting a second knee surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | MicroPort Orthopedics Inc. Industry-sponsored |
| Locations | 1 site (Milan, Piazza C. Ferrari 1 20122 Milan) |
| Trial ID | NCT06142669 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals who have previously undergone or are scheduled for a revision knee arthroplasty requiring the specific components being studied.
Not a fit: Patients who are skeletally immature, have an active infection, or inadequate neuromuscular status may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable long-term data on the effectiveness and safety of a new knee revision implant system, potentially improving patient outcomes.
How similar studies have performed: Other studies evaluating similar knee revision implant systems have shown promising results, indicating that this approach is supported by existing clinical evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan, Piazza C. Ferrari 1 20122 Milan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.