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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03903731




Registration number
NCT03903731
Ethics application status
Date submitted
26/03/2019
Date registered
4/04/2019
Date last updated
12/07/2019

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 - Journey II BCS Total Knee System

Treatment: Devices: 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 - We are measuring the number of revision cases
Timepoint [1] 0 0
12 Weeks
Secondary outcome [1] 0 0
Adverse Events - Number of adverse events reported per ISO 14155 guidelines
Timepoint [1] 0 0
implantation through study completion, approximately 8 years
Secondary outcome [2] 0 0
Health care utilization: Hospitalization - Length of hospital stay for primary (index) surgery
Timepoint [2] 0 0
implantation through study completion, approximately 8 years
Secondary outcome [3] 0 0
Health care utilization: Hospitalization - Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery
Timepoint [3] 0 0
implantation through study completion, approximately 8 years
Secondary outcome [4] 0 0
Health care utilization: Hospitalization - Length of stay for hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery
Timepoint [4] 0 0
implantation through study completion, approximately 8 years
Secondary outcome [5] 0 0
Health care utilization: Rehabilitation - number of sessions and duration of rehabilitation in weeks
Timepoint [5] 0 0
implantation through study completion, approximately 8 years
Secondary outcome [6] 0 0
Health care utilization: Outpatient visits - Number of outpatient visits
Timepoint [6] 0 0
implantation through study completion, approximately 8 years
Secondary outcome [7] 0 0
Health care utilization: Outpatient visits - Type of outpatient visits
Timepoint [7] 0 0
implantation through study completion, approximately 8 years
Secondary outcome [8] 0 0
Health Care Utilization: Re-operations - number of re-operations and revisions
Timepoint [8] 0 0
implantation through study completion, approximately 8 years
Secondary outcome [9] 0 0
Patient reported outcome implantation - EQ-5D-3L - Change in quality of life from baseline to one year postoperatively by answering quality of life questions on a 1-5 scale with 1 representing "never" and 5 representing "always"
Timepoint [9] 0 0
implantation through study completion, approximately 8 years
Secondary outcome [10] 0 0
Clinical outcomes - Knee Society Score - This validated tool combines an objective physician-derived component with a subjective subject-derived component. The objective section rates alignment, instability, joint motion and symptoms.
Timepoint [10] 0 0
implantation through study completion, approximately 8 years
Secondary outcome [11] 0 0
Return to Work - Changes in employment status will be recorded with the date on which the change occurred and the change status.
Timepoint [11] 0 0
implantation through study completion, 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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/NCT03903731
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Beate Hanson, MD, PhD
Address 0 0
Vice President, Clinical Strategy
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sandra Navarrete
Address 0 0
Country 0 0
Phone 0 0
512-895-1086
Fax 0 0
Email 0 0
Sandra.navarrete@smith-nephew.com
Contact person for scientific queries

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