JOURNEY™ II CR Total Knee System

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement.

Detailed Description
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This is a prospective, non-randomized, single cohort, multicenter study to evaluate the clinical outcomes of TKA using the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement. One hundred and seventy (170) subjects will be enrolled at up to 18 clinical sites globally. Follow-up clinical assessments will be performed at 3 months, 1 year, 2 years, 5 years, and 10 years post-operatively.

Official Title
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A Prospective, Non-randomized, Single Cohort, Multicenter Study to Evaluate the Clinical Outcomes of Total Knee Arthroplasty (TKA) Using the JOURNEY™ II CR Total Knee System

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: JOURNEY™ II CR Total Knee System (J II CR TKS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects MUST meet ALL of the following criteria for inclusion in the study: Has signed the IRB/EC approved ICF specific to this study prior to study participation Is a male or female ≥ 22 and ≤ 75 years of age presenting with degenerative joint disease (DJD) of the knee Is a candidate for primary total knee arthroplasty with the JOURNEY™ II CR Total Knee System due to DJD, defined by one of the following: Post-traumatic arthritis Osteoarthritis Degenerative arthritis Is able to read and understand the approved Informed Consent Form and Patient Reported Outcome (PRO) assessments (written and oral) Is in general good health (as determined by the Investigator) based on screening assessments and medical history Is independent, ambulatory, and can comply with all post-operative evaluations plans to be available through ten (10) years post-operative follow-up Exclusion Criteria: Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria: Any of the following conditions in the index joint: does not require patella resurfacing has received a TKA or unicondylar arthroplasty has inadequate bone stock to support the device (e.g. severe osteopenia/osteoporosis) Any of the following conditions in the contralateral joint: has enrolled in the study for the contralateral knee has received TKA as a revision for a failed total or unicondylar knee arthroplasty has received a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning, as determined by Investigator Any of the following conditions of the hip: received contralateral or ipsilateral revision hip arthroplasty has ipsilateral hip arthritis resulting in flexion contracture has received a ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty, that is not fully healed and well-functioning, as determined by Investigator Has diagnosis of an immunosuppressive disorder Has presence of malignant tumor, metastatic, or neoplastic disease Has family history of severe osteoporosis/osteopenia Has a known allergy to study device or one or more of its components Has conditions that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease) Is receiving medication for the diagnosis of fibromyalgia has a lower extremity condition causing abnormal or restricted ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture) Is pregnant or plans to become pregnant during the study Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study and complete PROs, as determined by Investigator Has a BMI>40 Is currently enrolled in or has participated in another investigational drug, biologic, or device study within 3 months of enrollment Is currently involved in personal injury litigation or a worker's compensation claim Is facing current or impending incarceration Is known to be at risk for lost to follow-up, or failure to return for scheduled visits

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Device:JOURNEY™ II CR Total Knee System (J II CR TKS)<br>Subjects having TKA with JOURNEY™ II CR Total Knee System | Device: JOURNEY™ II CR Total Knee System (J II CR TKS)<br>* TKA with Journey II CR Total Knee System<br>* Other names: (J II CR TKS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equivalence in 1 year post-operative mean Range of Motion (ROM) in subjects receiving the J II CR TKS as compared to the literature reference mean ROM |  | 1 year post-op analysis | 
| Non-inferiority of the survival rate of the J II CR TKS with the reference survival rate of a literature reference at 5 and 10-years post-operatively |  | Up to 10 year post-operative analysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcomes: EuroQol 5D (EQ-5D) scale |  | Pre-Op to 10 yrs | 
| Clinical Outcomes: 2011 Knee Society Score (2011 KSS) clinical evaluation |  | Pre-Op to 10 yrs | 
| Clinical Outcomes: Self-Administered Patient Satisfaction Scale for Primary Hip and Knee Arthroplasty (SAPSS |  | Pre-Op to 10 yrs | 
| Health Economic Endpoints : Physical therapy visit quantification/duration |  | 30, 60, and 90-day hospital re-admission rate | 
| Health Economic Endpoints: Discharge destination(s)/length of stay |  | 30, 60, and 90 days | 
| Health Economic Endpoints: Unscheduled professional visits (e.g. hospital, emergency room, orthopedic clinic, primary care physician) |  | 30, 60, and 90 days | 
| Health Economic Endpoints: Concomitant medications/procedures associated with the knee |  | 30, 60, and 90 days | 
| Safety Endpoints:Adverse events, to be evaluated by type, frequency, severity, and relatedness to the study treatment. |  | Pre-Op to 10 yrs | 
| Safety Endpoints: Manipulations under anesthesia |  | Pre-Op to 10 yrs | 
| Safety Endpoints: Radiographic analysis |  | Pre-Op to 10 yrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, TKA, Degenerative Knee Disease