Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,694
- 试验地点
- 12
- 主要终点
- Revision Rate of Total Knee System
研究概览
简要总结
The objective of this study is to estimate the safety and performance of Journey II BCS TKS.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Revision Rate of Total Knee System
时间窗: implantation through study completion, approximately 3 years
Number of revisions
次要结局
- Adverse Events(implantation through study completion, approximately 3 years)
- Clinical outcomes(implantation through study completion, approximately 3 years)
- Patient reported outcomes(implantation through study completion, approximately 3 years)
- Health care utilization: Hospitalization(implantation through study completion, approximately 3 years)
- Health care utilization: Rehabilitation(implantation through study completion, approximately 3 years)
- Return to Work(implantation through study completion, approximately 3 years)
- Technical Difficulties Encountered During Device Implantation(implantation through study completion, approximately 3 years)
- Health care utilization: Outpatient visits(implantation through study completion, approximately 3 years)
- Health Care Utilization: Re-operations(implantation through study completion, approximately 3 years)