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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Journey II BCS Total Knee System | Subjects having TKA with Journey II BCS Total Knee System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Journey II BCS Total Knee System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Revision Rate of Total Knee System | Number of revisions | implantation through study completion, approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of adverse events reported per ISO 14155 guidelines | implantation through study completion, approximately 3 years |
| Health care utilization: Hospitalization | Length of hospital stay for primary (index) surgery |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Beate Hanson, MD, PhD | Vice President, Global Clinical Strategy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Orthopaedics | Aurora | Colorado | 80045 | United States | ||
| Andrews Research and Education Foundation |
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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 |
| Patient reported outcomes | EQ-5D-3L | implantation through study completion, approximately 3 years |
| Clinical outcomes | 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 |
| Gulf Breeze |
| Florida |
| 32571 |
| United States |
| Methodist Sports Medicine | Indianapolis | Indiana | 46280 | United States |
| Hospital for Special Surgery | New York | New York | United States |
| University Orthopaedics Center | State College | Pennsylvania | 16602 | United States |
| TN Orthopaedic Foundation for Education and Research | Knoxville | Tennessee | 37923 | United States |
| San Antonio Orthopaedic Specialists | San Antonio | Texas | 78258 | United States |
| Providence Regional Medical Center | Everett | Washington | 98021 | United States |
| Marra Knee and Shoulder Center | Wheeling | West Virginia | 26003 | United States |
| Jesse Ziekenhuis | Hasselt | Belgium |
| UZ Leuven Campus | Pellenberg | Belgium |
| Christen Ortho AG | Bern | Switzerland |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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