Total Knee Arthroplasty
Conditions
Keywords
rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomy
Brief summary
The objective of this study is to estimate the safety and performance of Journey II BCS TKS.
Detailed description
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.
Interventions
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II BCS Total Knee System for approved indication * The TKA occurred at least 12 weeks prior to enrollment * Subject records contain Patient Reported Outcome data obtained ≤3 months prior to as well as ≥6 months post-enrollment.
Exclusion criteria
* Subject received the JOURNEY II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revision Rate of Total Knee System | implantation through study completion, approximately 3 years | Number of revisions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes | implantation through study completion, approximately 3 years | Knee Society Score |
| Adverse Events | implantation through study completion, approximately 3 years | Number of adverse events reported per ISO 14155 guidelines |
| Health care utilization: Hospitalization | implantation through study completion, approximately 3 years | Length of hospital stay for primary (index) surgery |
| Health Care Utilization: Re-operations | implantation through study completion, approximately 3 years | number of re-operations and revisions |
| Patient reported outcomes | implantation through study completion, approximately 3 years | EQ-5D-3L |
| Health care utilization: Outpatient visits | implantation through study completion, approximately 3 years | Number and type of outpatient visits |
| 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 |
| Health care utilization: Rehabilitation | implantation through study completion, approximately 3 years | number of sessions and duration of rehabilitation in weeks |
Countries
Belgium, Switzerland, United States
Outcome results
None listed