10003 PRO Current Products

Exclusion Criteria

• •The Subject is a woman who is pregnant or lactating.
• •Contralateral knee has already been enrolled in this study.
• •Subject had a contralateral amputation.
• •Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
• •Subject is currently experiencing radicular pain from the spine.
• •Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months.
• •Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• •Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires.
• •Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication.
• •Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
• •Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
• •Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
• •Subject has a medical condition with less than 2 years of life expectancy.