Persona Revision Knee System Outcomes

Study Overview
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Brief Summary
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The study will evaluate the performance, clinical benefits and safety of the Persona Revision Knee System in patients who have received primary or revision total knee arthroplasty (TKA) treatment. This will be done using a multicenter, single-arm, consecutive series, retrospective cohort study with prospective follow-up.

Detailed Description
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Under study are the Persona® Revision Knee System (K181947 and K191625) implants and instrumentation, and any compatible devices being used in conjunction according to the Instructions for Use. This will be accomplished by retrospectively identifying patients who underwent primary or revision TKA with this system and inviting them to participate in prospective data collection at 1 and 2-years postoperative follow-up. As the device was not available for commercial use until late 2019, the retrospective portion will involve those activities that occurred per standard of care for participants. The primary endpoint for this study will be performance assessed by improvement in the 1989 Knee Society Clinical Rating System (KS) objective knee score (KS-KS) from baseline to 2 years (as evaluated using the overall group mean showing at least the Minimal Clinically Important Difference (MCID) of 5.4 points). A maximum of 20 sites will contribute to this study. There will be a maximum of 380 patients enrolled in the study.

Official Title
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Clinical Investigation to Demonstrate Performance, Safety and Clinical Benefits of the Persona Revision Knee System

Conditions
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Infection, Arthroplasty Complications, Knee Disease, Knee Osteoarthritis

Intervention / Treatment
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* Device: Persona Revision Knee System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female of at least 18 years of age at the time of screening. Signed an institutional review board approved informed consent. Willingness and ability to comply with the study procedures and visit schedules and ability to understand and follow oral and written post-operative care instructions. Previous medical diagnosis/ history of at least one of the following conditions requiring treatment using the Persona Revision Knee System within a pre-specified study variant configuration (cohort), in accordance with the instructions for use (IFU): Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis Collagen disorders, and/or avascular necrosis of the femoral condyle Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy Moderate valgus, varus, or flexion deformities The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery A pre-operative Knee Society Knee Score (objective assessment) ≤ 80. Exclusion Criteria: Presence of clinically observed active or suspected latent infection in the affected joint at the time of procedure. Previous history of infection in the affected joint that may affect the prosthetic joint. Presence of or history of local/systemic/distant focal infection that may affect or hematogenously spread to the prosthetic joint. Skeletal immaturity or insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and/or fixation to the prosthesis. Diagnosed with neuropathic arthropathy, osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb. Presence of a stable, painless arthrodesis in a satisfactory functional position in the affected joint. Severe instability of the affected joint secondary to the absence of collateral ligament integrity. Diagnosis of rheumatoid arthritis in conjunction with any of the following at the time of screening: An ulcer of the skin History of recurrent breakdown of the skin Use of steroids Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition. Pregnant or women planning to become pregnant during the time they will be participating in the study. Any documented clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the Investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study procedure. Any patient who is institutionalized, or with a known drug or alcohol dependence currently or within the last year.

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 |
| --- | --- |
| 1) Revision Splined CCK<br>Patients who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, constrained condylar knee (CCK) articular surface, Persona Revision femoral component, and splined femoral stem. | Device: Persona Revision Knee System<br>* Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.<br>|
| 2) Revision Cemented CCK<br>Patients who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, CCK articular surface, Persona Revision femoral component, and cemented femoral stem. | Device: Persona Revision Knee System<br>* Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.<br>|
| 3) Revision Splined PS/CPS<br>Patients who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, posterior stabilized/constrained posterior stabilized (PS/CPS) articular surface, Persona Revision femoral component, and splined femoral stem. | Device: Persona Revision Knee System<br>* Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.<br>|
| 4) Revision Cemented PS/CPS<br>Patients who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, PS/CPS articular surface, Persona Revision femoral component, and cemented femoral stem. | Device: Persona Revision Knee System<br>* Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.<br>|
| 5) Revision Splined PS/CPS<br>Patients who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, PS/CPS articular surface, Persona primary PS femoral component, with no femoral stem. | Device: Persona Revision Knee System<br>* Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.<br>|
| 6) Revision Cemented PS/CPS<br>Patients who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, PS/CPS articular surface, Persona primary PS femoral component, with no femoral stem. | Device: Persona Revision Knee System<br>* Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.<br>|
| 7) Revision Cemented CCK with 5 Degree Primary Tibia<br>Patients who were implanted with a cemented tibial stem, 5 degree Persona primary tibial component, CCK articular surface, Persona Revision femoral component, and cemented femoral stem. | Device: Persona Revision Knee System<br>* Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.<br>|
| 8) Primary Splined CCK/CPS/PS with 0 Degree Tibia<br>Patients with a primary implant (non-revision case) who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, CCK/PS/CPS articular surface, Persona Revision femoral component, and splined femoral stem. | Device: Persona Revision Knee System<br>* Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.<br>|
| 9) Primary Cemented CCK/PS/CPS with 0 Degree Tibia<br>Patients with a primary implant (non-revision case) who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, CCK/PS/CPS articular surface, Persona Revision femoral component, and cemented femoral stem. | Device: Persona Revision Knee System<br>* Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.<br>|
| 10) Primary Cemented CCK/PS/CPS with 5 Degree Primary Tibia<br>Patients with a primary implant (non-revision case) who were implanted with a cemented tibial stem, 5 degree Persona primary tibial component, CCK/PS/CPS articular surface, Persona Revision femoral component, and cemented femoral stem. | Device: Persona Revision Knee System<br>* Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Clinical Rating System objective knee score (KS-KS) | The primary endpoint for this study will be performance assessed by improvement in the 1989 Knee Society Clinical Rating System (KS) objective knee score (KS-KS) from baseline to 2 years (as evaluated using the overall group mean showing at least the minimal clinically important difference [MCID] of 5.4 points) The Knee Society objective knee score (KS-KS) assesses the knee joint by awarding points for pain, stability, and range of motion, with a minimum possible score of 0 and maximum possible score of 100. As described in Insall et al. (1989), 100 points will be obtained by a well-aligned knee prosthesis with no pain, [at least 121] degrees of motion, and negligible anteroposterior and mediolateral instability. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and frequency of adverse events. | Safety of the device will be assessed by evaluating the incidence and frequency of adverse events including (re-)revision of any component during the study in accordance with Regulation (EU) 2017/745 - Medical Device Regulation (MDR) Article 80(2) as well as Medical Devices Coordination Group (MDCG) 2020-10/1. | 2 years | 
| Numeric Rating Scale (NRS) Pain Score | Performance and clinical benefits will be assessed by evaluating improvements in patient reported outcome measures (PROMs) of the Numeric Rating Scale (NRS) pain scores from baseline to 2 years. The Numeric Rating Scale (NRS) pain is scored on a scale of 0 to 10. A score of 0 indicates that the patient is experiencing no pain in their knee joint while a score of 10 indicates that the patient is experiencing the worst possible pain in their knee joint. | 2 years | 
| Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr) | Performance and clinical benefits will be assessed by evaluating improvements in patient reported outcome measures (PROMs) for the Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr) subscale scores from baseline to 2 years. The Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr) is scored on a scale of 0 to 100. A score of 100 indicates that a patient is experiencing perfect knee health while a score of 0 indicates that a patient is experiencing total knee disability. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Revision, Total Knee, Medical Device, Safety, Performance, Primary, Clinical Benefits