An observational study in Total Knee Arthroplasty, sponsored by Smith & Nephew, Inc.. Completed at 12 sites in 3 countries. Per ClinicalTrials.gov, last updated 2019-03-28.
Sponsored by Smith & Nephew, Inc. · Observational
The objective of this study is to estimate the safety and performance of Journey II BCS TKS.
The objective of this study is to estimate the safety and performance of Journey II BCS TKS. Specifically, the study will establish revision rate, treatment- and device-related complications, and clinical outcomes in a large sample of subjects who received the study device. Subjects are screened consecutively, beginning at the earliest date of implantation at each investigative site. Further, reasons for revision will be collected and analyzed. An analysis will be performed to identify characteristics (patient, surgeon and surgical) associated with an increased risk for revision. Finally, clinical, functional and quality of life outcomes will be analyzed to the extent data is available, given the retrospective study design.
Sites will identify potential subjects by retrospectively reviewing their source documents in order to identify all patients who received TKA with the Journey II BCS TKS.
Exclusion Criteria:
Subjects having TKA with Journey II BCS Total Knee System
Device: Journey II BCS Total Knee System
Revision Rate of Total Knee System
Number of revisions
Time frame: implantation through study completion, approximately 3 years
Adverse Events
Number of adverse events reported per ISO 14155 guidelines
Time frame: implantation through study completion, approximately 3 years
Health care utilization: Hospitalization
Length of hospital stay for primary (index) surgery
Time frame: implantation through study completion, approximately 3 years
Health care utilization: Hospitalization
Hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery (number and length of stay)
Time frame: implantation through study completion, approximately 3 years
Health care utilization: Rehabilitation
number of sessions and duration of rehabilitation in weeks
Time frame: implantation through study completion, approximately 3 years
Health care utilization: Outpatient visits
Number and type of outpatient visits
Time frame: implantation through study completion, approximately 3 years
Health Care Utilization: Re-operations
number of re-operations and revisions
Time frame: implantation through study completion, approximately 3 years
Patient reported outcomes
EQ-5D-3L
Time frame: implantation through study completion, approximately 3 years
Clinical outcomes
Knee Society Score
Time frame: implantation through study completion, approximately 3 years
Return to Work
Changes in employment status will be recorded with the date on which the change occurred and the change status.
Time frame: implantation through study completion, approximately 3 years
Technical Difficulties Encountered During Device Implantation
Number of technical difficulties encountered with the device
Time frame: implantation through study completion, approximately 3 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Smith & Nephew, Inc.