Persona Partial Knee Clinical Outcomes Study

Ki vehet részt

• Patient is at least 18 years of age
• Patient qualifies for knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Partial Knee system
• Patient has participated in a study-related Informed Consent process
• Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent form
• Patient is willing and able to complete scheduled study procedures and follow-up evaluations
• Independent of study participation, patient is a candidate for the commercially available Persona Partial Knee, implanted in accordance with product labeling

Ki nem vehet részt

• Patient is currently participating in any other surgical intervention studies or pain management studies
• Infection, sepsis, and osteomyelitis
• Rheumatoid arthritis or other forms of inflammatory joint disease
• Insufficiency of the collateral, anterior or posterior cruciate ligaments which would preclude stability of the device
• Uncooperative patient or patient with neurologic disorders who is incapable of following directions
• Metabolic disorders which may impair bone formation
• Distant foci of infections which may spread to the implant site
• Vascular insufficiency, muscular atrophy, neuromuscular disease
• Charcot's disease
• Full thickness damage to the weight bearing area of the contralateral compartment
• Insufficient bone stock to provide adequate support and/or fixation to the prosthesis
• Osteomalacia
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
• Incomplete or deficient soft tissue surrounding the knee
• Fixed varus deformity (not passively correctable) of greater than 15 degrees
• Fixed flexion deformity (not passively correctable) of greater than 15 degrees
• Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)