Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03903731
Registration number
NCT03903731
Ethics application status
Date submitted
26/03/2019
Date registered
4/04/2019
Date last updated
12/11/2020
Titles & IDs
Public title
Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures
Query!
Scientific title
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcomes Measures
Query!
Secondary ID [1]
0
0
16-4049-08B
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
JIIPROMS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Journey II BCS Total Knee System
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Revision of one or more study device components
Query!
Assessment method [1]
0
0
We are measuring the number of revision cases
Query!
Timepoint [1]
0
0
Implantation through study completion, approximately 8 years
Query!
Secondary outcome [1]
0
0
Health care utilization: Rehabilitation
Query!
Assessment method [1]
0
0
Number of sessions and duration of rehabilitation in weeks
Query!
Timepoint [1]
0
0
Implantation through study completion, approximately 8 years
Query!
Secondary outcome [2]
0
0
Return to Work
Query!
Assessment method [2]
0
0
Changes in employment status will be recorded with the date on which the change occurred and the change status.
Query!
Timepoint [2]
0
0
Implantation through study completion, approximately 8 years
Query!
Secondary outcome [3]
0
0
Knee Society Score (KSS)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline through last study visit, approximately 8 years
Query!
Secondary outcome [4]
0
0
Visual Analogue Scale (VAS)
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline through last study visit, approximately 8 years
Query!
Secondary outcome [5]
0
0
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline through last study visit, approximately 8 years
Query!
Secondary outcome [6]
0
0
Total Knee Assessment Score
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline through last study visit, approximately 8 years
Query!
Secondary outcome [7]
0
0
Oxford Knee Assessment (OKS)
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline through last study visit, approximately 8 years
Query!
Secondary outcome [8]
0
0
Knee Injury and Osteoarthritic Outcome Score (KOOS)
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Baseline through last study visit, approximately 8 years
Query!
Secondary outcome [9]
0
0
Knee Injury and Osteoarthritic Outcome Score Jr (KOOS Jr)
Query!
Assessment method [9]
0
0
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).
Query!
Timepoint [9]
0
0
Baseline through last study visit, approximately 8 years
Query!
Secondary outcome [10]
0
0
SF-12 Version 1
Query!
Assessment method [10]
0
0
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)
Query!
Timepoint [10]
0
0
Baseline through last study visit, approximately 8 years
Query!
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.
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Retrospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
19/07/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
8/08/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
600
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Colorado
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
New York
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Tennessee
Query!
Country [4]
0
0
Belgium
Query!
State/province [4]
0
0
Leuven
Query!
Country [5]
0
0
New Zealand
Query!
State/province [5]
0
0
Hamilton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Smith & Nephew, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter
Study. Patient Reported Outcome Measures.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03903731
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Michael R. Dayton, MD
Query!
Address
0
0
Department of Orthopaedics, University of Colorado Denver
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03903731
Download to PDF