Non-inflammatory Degenerative Joint Disease
Conditions
Keywords
osteoarthritis, traumatic arthritis, avascular necrosis
Brief summary
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
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.
Interventions
DEVICEJourney UNI Unicompartmental Knee System
Lateral or medial knee compartment replacement
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Subject received a Journey UKS implant (consisting of a femoral component, tibial baseplate, and a tibial insert). 3. Subject was considered skeletally mature at the time of surgery and was at least 18 years of age. 4. 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. 5. 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
1. Subject has Body Mass Index (BMI) \> 40 within 1 month of surgery. 2. Subjects who have received the Journey UNI UKS as part of a revision surgery. 3. 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). 4. Subject has a known allergy to study device or one or more of its components. 5. 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. 6. Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days. 7. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant survival rate | 5 years | Did knee survive with no revision through 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life - EQ-5D - 3L | 5 Years | EuroQol Five Dimensions Questionnaire |
| Quality of Life - SAPSS | 5 Years | Self-Administered Patient Satisfaction Survey |
| Quality of Life - KSS | 5 Years | 2011 Knee Society Score |
| Adverse Events (AEs) | 5 Years | All AEs will be collected and reported |
| Radiographic Outcomes | 5 Years | Perform weight-bearing AP and lateral standard x-rays |
| Quality of Life - Forgotten Joint Score | 5 Years | 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. |
Countries
Canada, United States
Outcome results
None listed