Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty

Ki vehet részt

• Age 18 to 80 years old, inclusive
• Qualifies for a primary TKA based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:; Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; Collagen disorders and/ or avascular necrosis of femoral condyle; Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; Moderate valgus, varus or flexion deformities; The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee
• Participated in a study-related informed consent process
• Willing and able to provide written informed consent by signing and dating the IRB/EC approved informed consent form
• Willing and able to complete scheduled study procedures and follow-up evaluations
• Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee system implanted in accordance with product labelling

Ki nem vehet részt

• Currently participating in any other surgical intervention studies or pain management studies
• Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
• Previously received partial or total knee arthroplasty for the ipsilateral knee
• Any loss of musculature or neuromuscular disease that compromises the affected limb
• Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
• Known or suspected sensitivity or allergy to one or more of the implant materials
• Insufficient bone stock on femoral or tibial surfaces/
• Skeletal immaturity
• Neuropathic arthropathy
• Stable, painless arthrodesis in a satisfactory functional position
• Severe instability secondary to the absence of collateral ligament integrity
• Pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent, etc.)