Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK

The objectives of this study are:

• To estimate the individual component survivorship of EVOLUTION® Revision Tibia, EVOLUTION® Revision CCK Femur, and EVOLUTION® CCK Tibial Insert.
• To find out the cumulative incidence of component revision of each component in this combination.
• To find out the functional outcome scores at early, midterm, and long-term follow-up.

Inclusion criteria

• Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires the study (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert)
• Decision to perform the study index surgery with the required study components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) is pre-determined regardless of the research.
• Previously implanted subjects must be enrolled within 3 years (+6 months) of their study index surgery
• Willing and able to complete required study visits and assessments through the 10 year post-operative follow-up visit.

Bilateral subjects can have both TKAs enrolled in the study provided:

• the specified combination of components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) were implanted in both
• all other aspects of the Inclusion/Exclusion Criteria are satisfied
• enrollment does not exceed the subject count specified
• the subject agrees to a second Informed Consent document and data collection specific to the second TKA.

Exclusion criteria

• Skeletally immature (less than 21 years of age) at time of implantation.
• Has an overt infection at the time of implantation.
• Has 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 would affect the endpoints of this protocol.
• Has documented substance abuse issues.
• Has 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.