Journey II BCS Total Knee SystemJIIPROMSNCT03903731
Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures
An observational study of Journey II BCS Total Knee System, run by Smith & Nephew, Inc. at 5 sites in 3 countries.
Trial summary
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Journey II BCS Total Knee System
- What is being tested?
- Total knee arthroplasty with Journey II BCS Total Knee System
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 19 Jul 2018to 8 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who received the Journey II BCS Total Knee System
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Department of Orthopaedics, University of Colorado Denver
Aurora, Colorado, 80045
Tennessee Orthopaedic Clinics
Knoxville, Tennessee, 37922
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcomes Measures
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.
- Conditions
- Journey II BCS Total Knee System
- Being tested
- Total knee arthroplasty with Journey II BCS Total Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasty with Journey II BCS Total Knee SystemDevice
Journey II BCS Total Knee System
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision of one or more study device components
We are measuring the number of revision cases
Measured: Implantation through study completion, approximately 8 years
Secondary outcomes (10)
Health care utilization: Rehabilitation
Number of sessions and duration of rehabilitation in weeks
Measured: Implantation through study completion, approximately 8 years
Return to Work
Changes in employment status will be recorded with the date on which the change occurred and the change status.
Measured: Implantation through study completion, approximately 8 years
Knee Society Score (KSS)
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.
Measured: Baseline through last study visit, approximately 8 years
Visual Analogue Scale (VAS)
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.
Measured: Baseline through last study visit, approximately 8 years
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
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.
Measured: Baseline through last study visit, approximately 8 years
Total Knee Assessment Score
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.
Measured: Baseline through last study visit, approximately 8 years
Oxford Knee Assessment (OKS)
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.
Measured: Baseline through last study visit, approximately 8 years
Knee Injury and Osteoarthritic Outcome Score (KOOS)
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.
Measured: Baseline through last study visit, approximately 8 years
Knee Injury and Osteoarthritic Outcome Score Jr (KOOS Jr)
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).
Measured: Baseline through last study visit, approximately 8 years
SF-12 Version 1
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)
Measured: Baseline through last study visit, approximately 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start19 Jul 2018
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Journey II BCS Total Knee SystemStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael R. Dayton, MD, Principal investigator, Department of Orthopaedics, University of Colorado DenverDavid J. Mayman, MD, Principal investigator, Hospital for Special Surgery, New YorkHarold E. Cates, MD, Principal investigator, Tennessee Orthopaedic ClinicsHilde Vandenneucker, MD, Principal investigator, UZ LeuvenPeter Black, MBBCh, Principal investigator, Anglesea Clinic Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903731
- Sponsor's protocol ID
- 16-4049-08B
- Acronym
- JIIPROMS
- Status last verified
- Nov 2020
- First submitted
- 26 Mar 2019
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcomes Measures
- ClinicalTrials.gov ID
- NCT03903731
- Acronym / sponsor ID
- JIIPROMS / 16-4049-08B
- Conditions
- Journey II BCS Total Knee System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who received the Journey II BCS Total Knee System
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee arthroplasty with Journey II BCS Total Knee SystemJourney II BCS Total Knee System | Device | – |
Primary outcome
Revision of one or more study device components
Time frame: Implantation through study completion, approximately 8 years
We are measuring the number of revision cases
10 secondary outcomes
Health care utilization: Rehabilitation
Time frame: Implantation through study completion, approximately 8 years
Return to Work
Time frame: Implantation through study completion, approximately 8 years
Knee Society Score (KSS)
Time frame: Baseline through last study visit, approximately 8 years
Visual Analogue Scale (VAS)
Time frame: Baseline through last study visit, approximately 8 years
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
Time frame: Baseline through last study visit, approximately 8 years
Total Knee Assessment Score
Time frame: Baseline through last study visit, approximately 8 years
Oxford Knee Assessment (OKS)
Time frame: Baseline through last study visit, approximately 8 years
Knee Injury and Osteoarthritic Outcome Score (KOOS)
Time frame: Baseline through last study visit, approximately 8 years
Knee Injury and Osteoarthritic Outcome Score Jr (KOOS Jr)
Time frame: Baseline through last study visit, approximately 8 years
SF-12 Version 1
Time frame: Baseline through last study visit, approximately 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael R. Dayton, MD principal investigator
Department of Orthopaedics, University of Colorado Denver
David J. Mayman, MD principal investigator
Hospital for Special Surgery, New York
Harold E. Cates, MD principal investigator
Tennessee Orthopaedic Clinics
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Journey II BCS Total Knee System, run by Smith & Nephew, Inc. at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Belgium, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revision of one or more study device components (time frame: Implantation through study completion, approximately 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.