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

Launched by MICROPORT ORTHOPEDICS INC. · Nov 16, 2023

Keywords

ClinConnect Summary

The EVOLUTION® Revision study is examining the safety and effectiveness of specific knee replacement devices used in patients who need a revision knee surgery. This means that the study is looking at people who have had knee surgery before but need another operation to replace or fix their knee implants. The devices being tested include the EVOLUTION® Revision Tibial System and the EVOLUTION® STEMMED CS Femur, along with an insert called the EVOLUTION® MP CS Tibial Insert. This research is important because it helps ensure that these medical devices continue to work well over time.

To participate in this study, candidates must be at least 21 years old and have a planned revision knee surgery with the devices being studied. They should be willing to sign a form that explains the study and agree to follow up for 10 years after their surgery. It’s important to note that individuals with certain medical conditions, infections, or those currently involved in other clinical studies may not be eligible. If someone joins the study, they can expect regular check-ins and assessments to monitor their recovery and the performance of the knee devices.

Gender

ALL

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