- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03442231
Journey™ UNI Post Market Clinical Follow-Up (Journey UNI)
February 15, 2024 updated by: Smith & Nephew, Inc.
Follow-Up of Subjects With a Journey™ UNI Unicompartmental Knee System Implant
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
147
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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London, Ontario, Canada, N6A5A5
- London Health Sciences Centre-University Hospital
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-
-
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Arizona
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Scottsdale, Arizona, United States, 85255
- Orthopaedic Specialists of Central Arizona-Scottsdale
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Illinois
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Park Ridge, Illinois, United States, 60068
- Orthopaedic Surgery Specialists, Ltd.
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Tennessee
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Nashville, Tennessee, United States, 37209
- Tennesee Orthopaedic Alliance, P.A.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Investigators will pre-screen all subjects that have previously undergone UKA using the Journey UNI UKS system between 12 and 48 months previously using only the existing information in the medical records.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Journey™ UNI Unicompartmental Knee System
Subjects previously received knee replacement
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Lateral or medial knee compartment replacement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implant survival rate
Time Frame: 5 years
|
Did knee survive with no revision through 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life - KSS
Time Frame: 5 Years
|
2011 Knee Society Score
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5 Years
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Quality of Life - EQ-5D - 3L
Time Frame: 5 Years
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EuroQol Five Dimensions Questionnaire
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5 Years
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Quality of Life - SAPSS
Time Frame: 5 Years
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Self-Administered Patient Satisfaction Survey
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5 Years
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Quality of Life - Forgotten Joint Score
Time Frame: 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.
|
5 Years
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Adverse Events (AEs)
Time Frame: 5 Years
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All AEs will be collected and reported
|
5 Years
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Radiographic Outcomes
Time Frame: 5 Years
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Perform weight-bearing AP and lateral standard x-rays
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5 Years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Salima Reddy, Smith & Nephew, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2018
Primary Completion (Estimated)
April 11, 2025
Study Completion (Estimated)
April 11, 2025
Study Registration Dates
First Submitted
February 16, 2018
First Submitted That Met QC Criteria
February 16, 2018
First Posted (Actual)
February 22, 2018
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 15, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-4049-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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