The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty
Patient is of legal age and skeletally mature
Patient is willing and able to provide written Informed Consent by signing and dating the Institutional Review Board (IRB) / Ethics Committee (EC) approved Informed Consent document
Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
Independent of study participation, patient qualifies for either cemented or cementless primary or revision total knee arthroplasty (including salvage of previously failed surgical attempts) based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling
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
The study population will be a subset of the US population electing to proceed with total knee arthroplasty irrespective of participation in the study and: 1) who will be receiving one or more of the components of interest as part of standard clinical care, 2) agree to participate by completing a study-specific informed consent form, and 3) who satisfy the inclusion/exclusion criteria.
Cohort
Prospective
Total Knee Arthroplasty
DeviceTotal knee replacement.
12
Treatment groupsSee each treatment group below.
Oxford Knee Score (OKS)
A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome.
EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure
A questionnaire completed by the patient and assesses his/her general health status. This score ranges from -0.573 to 1, with higher recorded scores indicating better overall health.
Pain and Satisfaction Numeric Rating Scale (NRS)
Patients will rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"). Along with their pain rating, subjects will be asked to rate their current satisfaction with their surgery from "Very Dissatisfied" to "Very Satisfied".
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