NCT03798847已完成不适用
Safety and Performance of Journey II XR Total Knee System. A Retrospective, Multicenter Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 683
- 试验地点
- 12
- 主要终点
- Revision of one or more study device components
研究概览
简要总结
The objective of this study is to estimate the safety and performance of Journey II XR TKS based on retrospective data.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication;
- •The TKA occurred at least 12 weeks prior to enrollment.
排除标准
- 未提供
结局指标
主要结局
Revision of one or more study device components
时间窗: 12 weeks follow up
Measure of the number of revision cases
次要结局
- Health Care Utilization: Re-operations(Implantation through study completion, approximately 3 years)
- Health care utilization: Hospitalization(Implantation through study completion, approximately 3 years)
- Health care utilization: Outpatient visits(Implantation through study completion, approximately 3 years)
- Technical Difficulties Encountered During Device Implantation(Implantation through study completion, approximately 3 years)
- Adverse Events(12 weeks follow up)
- Health care utilization: Rehabilitation(Implantation through study completion, approximately 3 years)
- Quality of Life: EQ-5D-3L(Implantation through study completion, approximately 3 years)
- Return to Work(Implantation through study completion, approximately 3 years)
- Quality of Life: KSS(Implantation through study completion, approximately 3 years)
研究者
研究点 (12)
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