JOURNEY II XR Safety and Effectiveness PMCF

Study Overview
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Brief Summary
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This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All participants will be implanted with the JOURNEY II XR total knee system.

Detailed Description
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Total knee arthroplasty (TKA) is considered the most beneficial and cost-effective treatment for end-stage knee arthritis and is the most frequently performed joint replacement surgery. TKA is also indicated for earlier osteoarthritis (OA) interventions, such as osteotomy or unicompartmental replacement, when additional treatment is warranted. One device option available once the decision is made to perform TKA is the JOURNEY II XR Total Knee System. The JOURNEY II XR Total Knee System is designed to be a more natural feeling total knee replacement. The goal of the JOURNEY II XR is to enable a higher level of function after total knee replacement by relieving pain and restoring the ability to participate in active lifestyles. The main aim of this study is to generate long-term safety and performance data for the JOURNEY™ II XR Total Knee System. Effectiveness information such as short- and long-term function, subject satisfaction, and quality of life will also be measured.

Official Title
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A Prospective, Multicenter, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of the JOURNEY™ II XR Total Knee System

Conditions
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Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee, Unilateral Post-Traumatic Osteoarthritis of Knee, Knee Osteoarthritis, Degenerative Arthritis Peripheral Joint, Failed Osteotomies, Failed Unicompartmental Replacement

Intervention / Treatment
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* Device: JOURNEY II XR Total Knee System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: require TKA due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, failed osteotomies, or failed unicompartmental replacement have all cruciate and collateral ligaments intact in the index joint adult patients that in the judgement of the Investigator are skeletally mature be willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires consent to participate in the study by signing the IRB/EC approved informed consent form Exclusion Criteria: have any of the following conditions in the index joint: Intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment Significant varus or valgus deformities (>15º) Incomplete or insufficient tissue surrounding the knee Collateral ligament insufficiency Inadequate bone stock to support the device (e.g., severe osteopenia/osteoporosis) or will require use of femoral and tibial stems History of prior TKA have any of the following conditions in the contralateral joint: a previous TKA as a revision for a failed total or unicondylar knee arthroplasty a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning as determined by the Investigator have any of the following conditions of the hip: a previous contralateral or ipsilateral revision hip arthroplasty ipsilateral hip arthritis resulting in flexion contracture previously received an ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty that is not fully healed and well-functioning as determined by the Investigator have a diagnosis of an immunosuppressive disorder have an active infection, treated or untreated, systemic or at the site of the planned surgery have conditions that may interfere with the TKA survival or outcome, including but not limited to: Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease have a BMI > 40 be facing current or impending incarceration have a known allergy to study device or one or more of its components be pregnant or have plans to become pregnant during the course of the study have, in the opinion of the Investigator, an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse be enrolled in another drug, biologic, or device study within 30 days of screening be known to be at risk for lost to follow-up or failure to return for scheduled visits during the surgery, have a cruciate ligament tibial bone island that is secured with any fixative device (e.g. screw, plate, etc.).

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 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 |
| --- | --- |
| JOURNEY II XR TKA<br>This is a single arm study, all subjects will receive JOURNEY II XR TKA | Device: JOURNEY II XR Total Knee System<br>* JOURNEY II XR Total Knee System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival rate | Did knee survive with no revision through 10 years | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee function | Lateral Step-Up Test | 10 years | 
| Quality of Life - EQ-5D - 3L | Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire | 10 years | 
| Quality of Life - FJS | Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire | 10 years | 
| Quality of Life - KOOS | Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS) questionnaire | 10 years | 
| Quality of Life - ABC scale | Patient Reported Outcomes using Activities-specific Balance Confidence (ABC) questionnaire | 10 years | 
| Quality of Life - SAPSS | Patient Reported Outcomes using Self-Administered Patient Satisfaction Score (SAPSS) questionnaire | 10 years | 
| Physiotherapy (PT) utilization - No. of visits | Number of PT visits required up to 6 months after surgery | 6 Months Post-operatively | 
| Physiotherapy (PT) utilization - Period of visits | Time period during which PT appointments are required up to 6 months after surgery | 6 Months Post-operatively | 
| Radiographic outcomes | X-rays of index joint | 10 years | 
| Adverse Events (AEs) | All AEs will be collected and reported | 10 years |