China ATTUNE® Study

Exclusion Criteria

• •1. The Subject has, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study, e.g. living in distant areas or having difficulty to return to the site, incooperative to surgeons' medical instructions and suggestions.
• •2. The Subject is a woman who is pregnant or lactating.
• •3. The 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 follow-up care or treatment outcomes.
• •4. The Subject has participated in a clinical investigation with an investigational product in the last 3 months that could impact/affect the outcome of the current procedure and follow-ups judged by the investigator.
• •5. The Subject has previous prosthetic knee replacement (any type including unicompartmental, total knee arthroplasty, patellofemoral arthroplasty or ipsilateral Upper Tibial Osteotomy (UTO)/ High Tibial Osteotomy (HTO)) of the affected knee or a previous patellectomy.
• •6. Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot disease, avascular necrosis).
• •7. The Subject requires a device not specified in the protocol or the surgeon determines that the ATTUNE Knee System is not a suitable treatment.