Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts

Más betegség

• Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study

Életkor

• Subject was skeletally immature (less than 21 years of age) at time of implantation

Egyéb

• Subjects will be excluded if they meet any of the following criteria:
• Subject is currently enrolled in another clinical investigation
• Subject is unwilling or unable to sign the Informed Consent document
• Subject has documented substance abuse issues
• Subject has a body mass index (BMI) of greater than 40
• Subject is currently incarcerated or has impending incarceration

• To be included in the study, subjects must meet all of the following criteria:
• Has previously undergone primary TKA for any of the following:
• non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
• inflammatory degenerative joint disease including rheumatoid arthritis
• correction of functional deformity.
• Subject was implanted with the specified combination of components
• Subject is willing and able to complete required study visits and assessments
• Subject plans to be available through the 10 year postoperative follow-up visit
• Subject is willing to sign the approved Informed Consent document
• Subject must be at least 2 years post TKA prior to informed consent.
  • Previously implanted bilateral subjects can have both TKAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 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 specific to the second TKA. Prospective enrollment of a previously unimplanted knee is not permitted in this study.