Persona Ti-Nidium Post-Market Clinical Follow-up

Korábbi kezelés

• Patient is currently participating in any other surgical intervention or pain management study
• Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
  • Study Device Exclusion Criteria
• Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint

Más betegség

• Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
• Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study
• Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
• Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
• The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with medial collateral ligament (MCL) insufficiency

Egyéb

• Patient is unwilling to sign the Informed Consent
• Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
• Insufficient bone stock on femoral or tibial surfaces
• Skeletal immaturity
• Neuropathic arthropathy
• A stable, painless arthrodesis in a satisfactory functional position
• Severe instability secondary to the absence of collateral ligament integrity

• Patient is of legal age and skeletally mature
• Patient is willing and able to provide written Informed Consent by signing and dating the IRB-approved Informed Consent document
• Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
• Patient qualifies for total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Ti-Nidium Knee System and Vivacit-E polyethylene articulating surface
• Independent of study participation, patient is a candidate for the commercially available Persona Ti-Nidium Knee and Vivacit-E polyethylene articulating surface, implanted in accordance with product labeling
  • Study Device Inclusion Criteria:
  • The Persona Ti-Nidium Total Knee is intended for patients with severe pain and disability due to the following:
• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.