Clinical Care Continuum (C3) Total Joint Patient Registry
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 3 months
研究概览
简要总结
This study will assess the efficacy of products, implants, and procedures for knee and hip replacement.
详细描述
This registry will prospectively collect a core set of data on patients undergoing knee or hip replacement. This registry will include a variety of different products, implants, technologies and procedures. The registry will also collect any adverse events/complications that occur during or following these surgeries. This database can also be utilized in the future to answer research questions, by retrospectively going back through the data. This information also may go to insurance companies or hospitals for quality measurement and metrics reporting. The data will be utilized to develop strategic treatment pathways that will improve patient care. Ultimately, the goal of the registry is to enhance the understanding of treatment associated with knee and hip replacement and the resulting patient outcomes. The registry will also be used to provide quality measurement and metrics reporting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •At least 18 years of age
- •Undergoing knee or hip replacement
- •Subject is likely to follow standard of care post-operative follow up for at least 1 year
排除标准
- •Inability to complete follow-up visits or required questionnaires
- •Inability to provide informed consent without a legally authorized representative
结局指标
主要结局
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 3 months
时间窗: baseline and 3 months
Assessment of hip symptoms and disability to be taken at baseline and 3 months after surgery
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 6 months
时间窗: baseline and 6 months
Assessment of hip symptoms and disability to be taken at baseline and 6 months after surgery
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 1 year
时间窗: baseline and 1 year
Assessment of hip symptoms and disability to be taken at baseline and 1 year after surgery
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 3 months
时间窗: baseline and 3 months
Assessment of knee symptoms and disability to be taken at baseline and 3 months after surgery
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 1 year
时间窗: baseline and 1 year
Assessment of knee symptoms and disability to be taken at baseline and 1 year after surgery
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 6 months
时间窗: baseline and 6 months
Assessment of knee symptoms and disability to be taken at baseline and 6 months after surgery
次要结局
- Adverse Events at time of surgery(Time of surgery)
- Adverse Events at 6 weeks after surgery(6 weeks after surgery)
- Adverse Events at 3 months after surgery(3 months after surgery)
- Adverse Events at 6 months after surgery(6 months after surgery)
- Adverse Events at 1 year after surgery(1 year after surgery)