Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Study Overview
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Brief Summary
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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

Detailed Description
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The study design is a prospective, multicenter data collection model of the 510(k) cleared Persona Total Knee System. The study will require each site to obtain institutional review board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process. All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty (TKA). Investigators will collect clinical data for a required 5 years. Follow-up clinical visits include 3 months, 1, 2, and 5 years post-operatively. Specific assessments include: Confirming the safety, performance and clinical benefits of the Persona total knee system and instrumentation in primary and revision TKA. Verifying that, under normal use, the performance and clinical benefits of this device and its instrumentation conform to those intended by the manufacturer by recording patient-reported clinical outcomes measures (PROMs) and radiographic outcomes (if available).

Official Title
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Persona® OsseoTi® Keel Compatibility Study-A Multicenter Cohort Study A Prospective, Post-market Clinical Follow-up Study to Demonstrate Safety, Performance and Clinical Benefits of the Persona Knee System Portfolio and Its Instrumentation

Conditions
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Osteoarthritis, Knee, Knee Pain Chronic, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis, Varus Deformity, Valgus Deformity, Flexion Deformity of Knee, Avascular Necrosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Cementless Femur Cementless Tibia | |
| Cohort 2<br>Cementless Femur Cementless Tibia | |
| Cohort 3<br>Cemented Femur Cemented Tibia | |
| Cohort 4<br>Cemented Femur Cemented Tibia | |
| Cohort 5<br>Cementless Femur Cemented Tibia | |
| Cohort 6<br>Cementless Femur Cemented Tibia | |
| Cohort 7<br>Cementless Femur Cemented Tibia | |
| Cohort 8<br>Cementless Femur Cemented Tibia | |
| Cohort 9<br>Cementless Femur Cementless Tibia | |
| Cohort 10<br>Cementless Femur Cementless Tibia | |
| Cohort 11<br>Intended to capture on-label configurations of newly cleared components not captured in cohorts 1-10. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 
| 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Total Knee Arthroplasty