Persona Total Knee Arthroplasty Outcomes Study

Korábbi kezelés

• Patient is 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
• Patient has previously received partial or total knee arthroplasty for the ipsilateral knee

Más betegség

• Osteoporosis or 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
• Patient has a known or suspected sensitivity or allergy to one or more of the implant materials

Egyéb

• 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
• Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)

• Patient 18-75 years of age, inclusive
• Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: a) rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the femoral condyle; c) post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate valgus, varus, or flexion deformities; or e) the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee
• 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 or 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 commercially available Persona fixed bearing knee components implanted in accordance with product labeling