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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
Date last updated
12/11/2020

Titles & IDs
Public title
Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures
Scientific title
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcomes Measures
Secondary ID [1] 0 0
16-4049-08B
Universal Trial Number (UTN)
Trial acronym
JIIPROMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Journey II BCS Total Knee System 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Revision of one or more study device components
Timepoint [1] 0 0
Implantation through study completion, approximately 8 years
Secondary outcome [1] 0 0
Health care utilization: Rehabilitation
Timepoint [1] 0 0
Implantation through study completion, approximately 8 years
Secondary outcome [2] 0 0
Return to Work
Timepoint [2] 0 0
Implantation through study completion, approximately 8 years
Secondary outcome [3] 0 0
Knee Society Score (KSS)
Timepoint [3] 0 0
Baseline through last study visit, approximately 8 years
Secondary outcome [4] 0 0
Visual Analogue Scale (VAS)
Timepoint [4] 0 0
Baseline through last study visit, approximately 8 years
Secondary outcome [5] 0 0
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
Timepoint [5] 0 0
Baseline through last study visit, approximately 8 years
Secondary outcome [6] 0 0
Total Knee Assessment Score
Timepoint [6] 0 0
Baseline through last study visit, approximately 8 years
Secondary outcome [7] 0 0
Oxford Knee Assessment (OKS)
Timepoint [7] 0 0
Baseline through last study visit, approximately 8 years
Secondary outcome [8] 0 0
Knee Injury and Osteoarthritic Outcome Score (KOOS)
Timepoint [8] 0 0
Baseline through last study visit, approximately 8 years
Secondary outcome [9] 0 0
Knee Injury and Osteoarthritic Outcome Score Jr (KOOS Jr)
Timepoint [9] 0 0
Baseline through last study visit, approximately 8 years
Secondary outcome [10] 0 0
SF-12 Version 1
Timepoint [10] 0 0
Baseline through last study visit, approximately 8 years

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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/08/2019
Sample size
Target
Accrual to date
Final
600
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
New Zealand
State/province [5] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Smith & Nephew, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.
Trial website
https://clinicaltrials.gov/study/NCT03903731
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael R. Dayton, MD
Address 0 0
Department of Orthopaedics, University of Colorado Denver
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03903731