An observational study in Journey II XR Total Knee System, sponsored by Smith & Nephew, Inc.. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-14.
Sponsored by Smith & Nephew, Inc. · Observational
The objective of this study is to estimate the safety and performance of Journey II XR TKS based on retrospective data.
Smith & Nephew, Inc. is the lead sponsor of 132 studies on the registry; 10 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication
Exclusion Criteria:
Journey II XR Total Knee System
Revision of one or more study device components
Measure of the number of revision cases
Time frame: 12 weeks follow up
Adverse Events
All collected and reported AEs
Time frame: 12 weeks follow up
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
Quality of Life: EQ-5D-3L
EuroQol Five Dimensions Questionnaire
Time frame: Implantation through study completion, approximately 3 years
Quality of Life: KSS
2011 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 Jul 2023. You cannot join it, but the record below documents what was studied.
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Smith & Nephew, Inc.