Journey™ UNI Post Market Clinical Follow-Up

Study Overview
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Brief Summary
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This is a retrospective/prospective, open-label single cohort, multicenter study to collect relevant clinical data from 147 subjects with unicompartmental degeneration of the knee in whom the Journey UNI UKS was previously implanted.

Detailed Description
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The purpose of the current investigation is to assess the safety and effectiveness of the JOURNEY UNI Unicompartmental Knee System (UKS) in patients with non-inflammatory degenerative joint disease (NIDJD) of the knee who previously had the Journey UNI UKS implanted. This clinical study will prospectively evaluate the 36 and 60-month safety and performance of the JOURNEY UNI UKS in patients with NIDJD of the knee who required lateral or medial knee compartment replacement.

Official Title
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Follow-Up of Subjects With a Journey™ UNI Unicompartmental Knee System Implant

Conditions
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Non-inflammatory Degenerative Joint Disease

Intervention / Treatment
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* Device: Journey UNI Unicompartmental Knee System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 12 and 48 months previously, subject had unicompartmental knee replacement implanted for unicompartmental, NIDJD including OA, traumatic arthritis, avascular necrosis, for correction of functional deformity, or to repair a fracture that was unmanageable using other techniques. Subject received a Journey UKS implant (consisting of a femoral component, tibial baseplate, and a tibial insert). Subject was considered skeletally mature at the time of surgery and was at least 18 years of age. Subject is willing to have retrospective data collected and to participate in required prospective follow-up visit(s) at the investigational site and to complete study procedures and questionnaires. Subject has consented to participate in the study by signing the Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent form (ICF). Exclusion Criteria: Subject has Body Mass Index (BMI) > 40 within 1 month of surgery. Subjects who have received the Journey UNI UKS as part of a revision surgery. Subject has a condition that may interfere with the unicompartmental knee arthroplasty (UKA) survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease). Subject has a known allergy to study device or one or more of its components. Subject, in the opinion of the Principal Investigator (PI), has an emotional or neurological condition that would preempt his/her ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse. Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.

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 |
| --- | --- |
| Journey™ UNI Unicompartmental Knee System<br>Subjects previously received knee replacement | Device: Journey UNI Unicompartmental Knee System<br>* Lateral or medial knee compartment replacement<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 5 years | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life - KSS | 2011 Knee Society Score | 5 Years | 
| Quality of Life - EQ-5D - 3L | EuroQol Five Dimensions Questionnaire | 5 Years | 
| Quality of Life - SAPSS | Self-Administered Patient Satisfaction Survey | 5 Years | 
| Quality of Life - Forgotten Joint Score | Forgotten Joint Score (FJS) questionnaire measures how often subject is aware of affected knee in everyday life. Score consists of 12 questions where subjects are asked to rate their awareness of their joint replacement during various activities. rating is never, almost never, seldom, sometimes or mostly. | 5 Years | 
| Adverse Events (AEs) | All AEs will be collected and reported | 5 Years | 
| Radiographic Outcomes | Perform weight-bearing AP and lateral standard x-rays | 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, traumatic arthritis, avascular necrosis