iAssist vs. Conventional Instrumentation in Total Knee Arthroplasty

Exclusion Criteria

• •Patient is currently enrolled in an investigational new drug or device study.
• •Patient has an active infection (including septic knee, distant infection, or osteomyelitis).
• •Patient has severe hip arthrosis.
• •Patient has neurological disorders (including, but not limited to Parkinson's disease).
• •Patient has had a prior ipsilateral unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy.
• •Patient has hip or knee ankylosis.
• •Patient has inflammatory joint disease.
• •Patient has rheumatoid knee arthritis.
• •Patient has indications of intra- and/or extra-articular deformations that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately sized implant, such as polio, history of tibial plateau fracture, etc.
• •Patient has any metal within 150 mm of the joint line for the operative-side knee.
• •Patient has knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination.
• •Female who is pregnant or lactating.
• •Patient currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• •Patient has arterial disease or stents that would exclude the use of a tourniquet.
• •Patient has insufficient quality or quantity of bone to support the implant due to prior knee surgery (or surgeries), cancer, metabolic bone disease, osteoporosis/osteopenia (diagnosed or treated with medication), active/old/remote infection, etc.
• •Patient has a mental condition that may interfere with his/her ability to give an informed consent or interfere with his/her ability or willingness to fulfill the requirements of the study.
• •Patient has a condition that would place excessive demands on the implant (e.g., Charcot's joints, muscle deficiencies, multiple joint disabilities, skeletal immaturity, etc.).
• •Patient has collateral ligament insufficiency.
• •Patient has an immunosuppressive disorder (e.g., AIDS, etc.) that would require cytotoxic drugs, corticosteroids, large dose of irradiation, or antilymphocytic serum.
• •Patient has an existing condition that would, in the opinion of the investigator, compromise participation or follow-up in this study.