Trials / Completed
CompletedNCT03292003
Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,694 (actual)
- Sponsor
- Smith & Nephew, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Journey II BCS Total Knee System |
Timeline
- Start date
- 2016-12-30
- Primary completion
- 2018-01-30
- Completion
- 2018-09-24
- First posted
- 2017-09-25
- Last updated
- 2019-03-28
Locations
12 sites across 3 countries: United States, Belgium, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03292003. Inclusion in this directory is not an endorsement.