About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Total Knee Arthroplasty
Treatment groups
12
Treatment groupsSee each treatment group below.