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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03903731
Registration number
NCT03903731
Ethics application status
Date submitted
26/03/2019
Date registered
4/04/2019
Titles & IDs
Public title
Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures
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Scientific title
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcomes Measures
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Secondary ID [1]
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16-4049-08B
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Universal Trial Number (UTN)
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Trial acronym
JIIPROMS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Journey II BCS Total Knee System
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Total knee arthroplasty with Journey II BCS Total Knee System
Treatment: Devices: Total knee arthroplasty with Journey II BCS Total Knee System
Journey II BCS Total Knee System
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Revision of one or more study device components
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Assessment method [1]
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We are measuring the number of revision cases
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Timepoint [1]
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Implantation through study completion, approximately 8 years
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Secondary outcome [1]
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Health care utilization: Rehabilitation
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Assessment method [1]
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Number of sessions and duration of rehabilitation in weeks
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Timepoint [1]
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Implantation through study completion, approximately 8 years
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Secondary outcome [2]
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Return to Work
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Assessment method [2]
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Changes in employment status will be recorded with the date on which the change occurred and the change status.
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Timepoint [2]
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Implantation through study completion, approximately 8 years
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Secondary outcome [3]
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Knee Society Score (KSS)
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Assessment method [3]
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Knee Society Score (KSS), a physician- and self-administered questionnaire consisting of several items to measure the outcomes; in this study, the following KOOS scores ranging from 0 to 100 were analyzed: Symptoms Score, Satisfaction Score, Expectation Score, Walking and Standing Score, Standard Activity Score, Advanced Activity Score, Discretionary Activity Score, and Functional Activities Score. Lower KSS scores indicated worse knee conditions.
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Timepoint [3]
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Baseline through last study visit, approximately 8 years
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Secondary outcome [4]
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Visual Analogue Scale (VAS)
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Assessment method [4]
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Visual Analogue Scale (VAS), a self-administered psychometric response instrument to evaluate subject-reported assessment of pain in each knee. There are multiple ways to present VAS scores; in this study, the numerical score ranged from 0 to 100 was used, with the higher score corresponding to the worse pain.
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Timepoint [4]
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Baseline through last study visit, approximately 8 years
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Secondary outcome [5]
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Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
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Assessment method [5]
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The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, a self-administered questionnaire consisting of several items (grouped into symptoms, function, daily living, pain, etc) to measure the outcomes using the scores: Total WOMAC score (sum of all scores), WOMAC pain score (range 0 to 20), WOMAC stiffness score (range 0 to 8), and WOMAC physical function score (range of 0 to 68). The higher WOMAC scores corresponded to worse outcomes.
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Timepoint [5]
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Baseline through last study visit, approximately 8 years
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Secondary outcome [6]
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Total Knee Assessment Score
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Assessment method [6]
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Total Knee Assessment score is a self-administered questionnaire comprising multiple-choice questions regarding subjects' knee-related pain and limitations in ability to work, sports, and other daily living activities. In this study, the numbers and percentages of subjects answering each multiple-choice question were summarized. The higher percentage of subjects giving an answer indicating a higher level of limitations was indicative of worse outcomes.
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Timepoint [6]
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Baseline through last study visit, approximately 8 years
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Secondary outcome [7]
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Oxford Knee Assessment (OKS)
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Assessment method [7]
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Oxford Knee Assessment (OKS) is a self-administered questionnaire comprising multiple-choice questions aimed to grade subjects' ability to perform daily activities. The overall score is the sum of all items and range from 0 to 48, with a higher score corresponding to better outcomes.
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Timepoint [7]
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Baseline through last study visit, approximately 8 years
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Secondary outcome [8]
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Knee Injury and Osteoarthritic Outcome Score (KOOS)
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Assessment method [8]
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Knee Injury and Osteoarthritic Outcome Score (KOOS) is a self -administered joint-specific questionnaire comprising questions regarding subject's symptoms, knee stiffness, pain, function and daily living, function and sports and recreational activities, and quality of life; in this study, the following KOOS scores ranging from 0 to 100 (with a score of 0 indicating the worst possible symptoms) were analyzed: Pain Score, Other Symptoms Score, Function in Daily Living Score, Function in Sport and Recreation Score, and Quality of Life Score.
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Timepoint [8]
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Baseline through last study visit, approximately 8 years
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Secondary outcome [9]
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Knee Injury and Osteoarthritic Outcome Score Jr (KOOS Jr)
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Assessment method [9]
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Knee Injury and Osteoarthritic Outcome Score Jr (KOOS Jr) is a shorter self-administered alternative to KOOS focusing on joint pain, stiffness, and daily living and allowing for faster completion by the subject. In this study, the KOOS Interval Score ranging from 0 to 100 was analyzed (with a score of 0 indicating the worst possible symptoms).
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Timepoint [9]
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Baseline through last study visit, approximately 8 years
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Secondary outcome [10]
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SF-12 Version 1
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Assessment method [10]
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SF-12 Version 1 is a self-administered multipurpose (not aimed to specific disease group) short form survey with questions selected from the longer SF-36 Health Survey and comprising the following scores: Physical Health Composite Score (range 0 for the worst health to 100 for the best health) and Mental Health Composite Score (range 0 for the worst health to 100 for the best health)
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Timepoint [10]
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Baseline through last study visit, approximately 8 years
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Eligibility
Key inclusion criteria
* Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II BCS Total Knee System for approved indication;
* The TKA occurred at least 12 weeks prior to enrollment
* Subject records contain Patient Reported Outcome data obtained =3 months prior to as well as =6 months post-enrollment.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Subject received the JOURNEY II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/08/2019
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Sample size
Target
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Accrual to date
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Final
600
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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Country [2]
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United States of America
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State/province [2]
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New York
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Country [3]
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United States of America
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State/province [3]
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Tennessee
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Country [4]
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Belgium
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State/province [4]
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Leuven
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Country [5]
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New Zealand
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State/province [5]
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Hamilton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Smith & Nephew, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.
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Trial website
https://clinicaltrials.gov/study/NCT03903731
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michael R. Dayton, MD
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Address
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Department of Orthopaedics, University of Colorado Denver
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03903731