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The objective of this study is to estimate the safety and performance of Journey II XR TKS based on retrospective data.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Journey II XR TKA | Device | Journey II XR Total Knee System |
| Measure | Description | Time Frame |
|---|---|---|
| Revision of one or more study device components | Measure of the number of revision cases | 12 weeks follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | All collected and reported AEs | 12 weeks follow up |
| Health care utilization: Hospitalization | Length of hospital stay for primary (index) surgery |
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Inclusion Criteria:
Exclusion Criteria:
- None
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Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Institute of the West | Phoenix | Arizona | 85054 | United States | ||
| Rush Copley Orthopaedics |
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| 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) | Implantation through study completion, approximately 3 years |
| Health care utilization: Rehabilitation | number of sessions and duration of rehabilitation in weeks | Implantation through study completion, approximately 3 years |
| Health care utilization: Outpatient visits | Number and type of outpatient visits | Implantation through study completion, approximately 3 years |
| Health Care Utilization: Re-operations | Number of re-operations and revisions | Implantation through study completion, approximately 3 years |
| Quality of Life: EQ-5D-3L | EuroQol Five Dimensions Questionnaire | Implantation through study completion, approximately 3 years |
| Quality of Life: KSS | 2011 Knee Society Score | 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. | Implantation through study completion, approximately 3 years |
| Technical Difficulties Encountered During Device Implantation | Number of technical difficulties encountered with the device | Implantation through study completion, approximately 3 years |
| Aurora |
| Illinois |
| 60504 |
| United States |
| Jerry Orthopaedic Institute | Port Huron | Michigan | 48060 | United States |
| Reno Orthopedic Clinic | Reno | Nevada | 89503 | United States |
| Orthopaedic Center of New Jersey | Somerset | New Jersey | 08873 | United States |
| Hospital for Joint Diseases Orthopaedics Institute | New York | New York | 10003 | United States |
| Regenerative Orthopedic Center (ROC) | Oregon City | Oregon | 97045 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| San Antonio Orthopaedic Specialists | San Antonio | Texas | 78258 | United States |
| Anderson Orthopaedic Clinic | Alexandria | Virginia | 22306 | United States |
| Scott Orthopedic Center | Huntington | West Virginia | 25702 | United States |
| Aurora Medical Center | Kenosha | Wisconsin | 53142 | United States |