Status:
RECRUITING
EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol
Lead Sponsor:
MicroPort Orthopedics Inc.
Conditions:
Joint Diseases
Eligibility:
All Genders
21+ years
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 Tibia...
Detailed Description
The primary objective of this study is to estimate individual component survivorship for tibial base, femoral component, and tibial insert at specified intervals out to 10 years follow-up. The second...
Eligibility Criteria
Inclusion
- 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)
- Decision to perform the study index surgery with the required study components is pre-determined regardless of the research;
- Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their study index surgery
- Willing to voluntarily sign the informed consent form
- 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
- Skeletally immature (less than 21 years of age) at time of implantation
- Has or had an overt infection at the time of implantation
- 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
- Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- Has or had documented substance abuse issues
- Has or had an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- Currently incarcerated or has impending incarceration
- 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
Key Trial Info
Start Date :
October 31 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2036
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06142669
Start Date
October 31 2023
End Date
December 1 2036
Last Update
January 22 2024
Active Locations (1)
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1
Gaetano Pini Orthopedic Institute
Milan, Piazza C. Ferrari 1 20122 Milan, Italy