Persona SoluTion PPS Femur PMCF

Ki vehet részt

• Patient is of legal age of consent and skeletally mature
• Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC 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® SoluTion® PPS femoral implant and appropriate compatible components, within a pre-specified variant configuration (cohort)
• A clinical decision has been made to use the Persona® SoluTion® PPS femoral implant prior to enrollment in the research

Ki nem vehet részt

• 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
• Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
• Study device not implanted during surgery, or surgery did not occur
• 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
• Patient requires simultaneous bilateral knee surgery for treatment of the diagnosed condition
• 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
• KOOS JR score not collected pre-operatively