Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert

Exclusion Criteria

• •3. enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
• •4. the subject agrees to a second Informed Consent document and data collection specific to the second TKA.
• •Bilateral subjects can have both TKAs enrolled in the study provided:
• •1. the specified combination of components (EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert) were implanted in both,
• •3. enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
• •4. the subject agrees to a second Informed Consent document and data collection specific to the second TKA.
• •Bilateral implantation can occur at different time periods for the same subject.
• •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 a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
• •4. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
• •5. 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
• •6. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
• •7. Has documented substance abuse issues
• •8. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
• •9. Currently incarcerated or has impending incarceration
• •10. 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