Persona Revision Knee System Outcomes

Exclusion Criteria14

• \) Presence of clinically observed active or suspected latent infection in the affected joint at the time of procedure.
• \) Presence of of local/systemic/distant focal infection that may affect or hematogenously spread to the prosthetic joint.
• \) Skeletal immaturity or insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and/or fixation to the prosthesis.
• \) Diagnosed with neuropathic arthropathy, osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb.
• \) Presence of a stable, painless arthrodesis in a satisfactory functional position in the affected joint.
• \) Severe instability of the affected joint secondary to the absence of collateral ligament integrity.
• \) Diagnosis of rheumatoid arthritis in conjunction with any of the following at the time of screening:
• An ulcer of the skin
• History of recurrent breakdown of the skin
• Use of steroids
• \) Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition.
• \) Pregnant or women planning to become pregnant during the time they will be participating in the study.
• \) Any documented clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the Investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study procedure.
• \) Any patient who is institutionalized, or with a known drug or alcohol dependence currently or within the last year.