14022 ATTUNE Cementless RP Clinical Performance Evaluation

Ki vehet részt

• Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive
• Subject was diagnosed with NIDJD
• Subject, in the opinion of the Investigator, is a suitable candidate for cementless primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae
• 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
• Subject is currently not bedridden
• 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
• Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROs in either English or one of the available translations

Ki nem vehet részt

• Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee
• Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months
• 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 their ability to complete patient reported questionnaires or be compliant with follow-up requirements
• 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
• Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis, Charcot disease)
• Subject has a medical condition with less than five (5) years life expectancy
• The Subject is a woman who is pregnant or lactating
• Contralateral knee has already been enrolled in this study
• Subject had a contralateral amputation
• Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA
• Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims
• Subject is suffering from inflammatory arthritis (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.)
• Uncontrolled gout