Journey II XR Total Knee System
Conditions
Keywords
Journey II XR Total Knee System
Brief summary
The objective of this study is to estimate the safety and performance of Journey II XR TKS based on retrospective data.
Interventions
DEVICEJourney II XR TKA
Journey II XR Total Knee System
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication; * The TKA occurred at least 12 weeks prior to enrollment.
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revision of one or more study device components | 12 weeks follow up | Measure of the number of revision cases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health care utilization: Hospitalization | implantation through study completion, approximately 3 years | Length of hospital stay for primary (index) surgery |
| Health care utilization: Rehabilitation | Implantation through study completion, approximately 3 years | number of sessions and duration of rehabilitation in weeks |
| Health care utilization: Outpatient visits | Implantation through study completion, approximately 3 years | Number and type of outpatient visits |
| Health Care Utilization: Re-operations | Implantation through study completion, approximately 3 years | Number of re-operations and revisions |
| Adverse Events | 12 weeks follow up | All collected and reported AEs |
| Quality of Life: KSS | Implantation through study completion, approximately 3 years | 2011 Knee Society Score |
| Return to Work | Implantation through study completion, approximately 3 years | Changes in employment status will be recorded with the date on which the change occurred and the change status. |
| Technical Difficulties Encountered During Device Implantation | Implantation through study completion, approximately 3 years | Number of technical difficulties encountered with the device |
| Quality of Life: EQ-5D-3L | Implantation through study completion, approximately 3 years | EuroQol Five Dimensions Questionnaire |
Countries
United States
Outcome results
None listed