NCT06142669 EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol
| NCT ID | NCT06142669 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MicroPort Orthopedics Inc. |
| Condition | Joint Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2023-10-31 |
| Primary Completion | 2036-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2023-10-31 with a primary completion date of 2036-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Pietro I Randelli, Prof
PRINCIPAL INVESTIGATOR
Gaetano Pini Orthopedic Institute
Frequently Asked Questions
Who can join the NCT06142669 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Joint Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06142669 currently recruiting?
Yes, NCT06142669 is actively recruiting participants. Contact the research team at joannamarie.becker@ortho.microport.com for enrollment information.
Where is the NCT06142669 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06142669 clinical trial?
NCT06142669 is sponsored by MicroPort Orthopedics Inc.. The principal investigator is Pietro I Randelli, Prof at Gaetano Pini Orthopedic Institute. The trial plans to enroll 45 participants.