Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Exclusion Criteria14

• Patient is currently participating in any other surgical intervention or pain management study
• Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
• Patient has a mental or neurological condition who is unwilling or incapable of following postoperative care instructions
• Patient has a condition which would, in the judgment of the investigator, place the patient at undue risk or interfere with the conduct of the study
• Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
• Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
• Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
• Insufficient bone stock on femoral or tibial surfaces
• Neuropathic arthropathy
• Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
• A stable, painless arthrodesis in a satisfactory functional position
• Severe instability secondary to the absence of collateral ligament integrity
• Rheumatoid Arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
• Patient has a \> 5˚ valgus deformity with a medial collateral ligament (MCL) insufficiency, and the surgeon intends to use the personalized alignment surgical technique