ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

Eligibility Criteria

• 1. Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive.
• 2. The decision to have knee replacement with the study device is regardless of the research.
• 3. The devices are to be used according to the approved indications.
• 4. Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor
• 5. Subject is currently not bedridden.
• 6. Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.
• 7. Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROMs in either English or one of the available translations.
• 8. Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.)
• 1. The Subject is a woman who is pregnant or lactating.
• 2. Contralateral knee has already been enrolled in this study. If the Investigator plans to treat a potential study subject with either simultaneous (two (2) knees in one (1) surgical setting) or staged bilateral TKA, then this subject may be enrolled; however, only the first knee may be enrolled into this study.
• 3. Subject had a contralateral amputation.
• 4. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) or primary TKA in affected knee.
• 5. Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
• 6. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
• 7. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• 8. Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect his/her ability to complete patient reported questionnaires or be compliant with follow-up requirements.
• 9. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
• 10. Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
• 11. Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator.
• 12. Subject has been diagnosed with an inflammatory arthritis (including uncontrolled gout, rheumatoid, psoriatic etc.).