California Joint Replacement Registry
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Number of Patients with Total Hip Replacement
研究概览
简要总结
The California Joint Replacement Registry (CJRR) was created to meet the need for comprehensive, scientific assessment of devices, treatment protocols, surgical approaches, and patient factors influencing the results of hip and knee replacement surgeries. Importantly, it is a Level 3 registry, meaning it collects and incorporates clinical information and direct feedback from patients about the outcomes of hip and knee replacement surgeries. It is one of only a small number of registries in the United States to do so.
The CJRR's goals are to:
- Collect and report scientifically valid data on the results of hip and knee replacements performed in California, including device safety and effectiveness, post-operative complication and revision rates, and patient-reported outcomes; and
- Promote the use of performance information regarding hip and knee replacements to guide physician and patient decisions and to support programs for provider recognition and reward.
Specifically the CJRR is designed to:
- Minimize burden on participants by using electronic data sources, rather than manual data entry or chart review.
- Compile reports assessing the outcomes associated with different devices and surgical techniques.
- Create benchmarking reports for physicians and hospitals that detail performance data and compare it to statewide averages.
- Transmit safety alerts on devices with short-term results that provoke concern.
- Shape a measurement and reporting system for total hip and total knee replacement surgeries.
The CJRR was developed by the California HealthCare Foundation (CHCF), the Pacific Business Group on Health (PBGH), and the California Orthopaedic Association (COA). PBGH manages the day-to-day operations of the CJRR.
CJRR's data elements are aligned with other major orthopedic registries. The CJRR is a member of the International Consortium of Orthopedic Registries (ICOR) and the International Society of Arthroscopic Registries (ISAR).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Receiving hip or knee replacement surgery in California.
排除标准
- 未提供
结局指标
主要结局
Number of Patients with Total Hip Replacement
时间窗: 3 months, 6 months, every year up to 5 years
Number of Patients with Partial Hip Replacement
时间窗: 3 months, 6 months, every year up to 5 years
Number of Patients with Hip Revision
时间窗: 3 months, 6 months, every year up to 5 years
Number of Patients with Total Knee Replacement
时间窗: 3 months, 6 months, every year up to 5 years
Number of Patients with Knee Revision
时间窗: 3 months, 6 months, every year up to 5 years
次要结局
- Number and Type of Adverse Events as a Measure of Patient Safety(3 months)
- Number and Type of Readmissions as a Measure of Surgical Quality(3 months, 6 months, every year up to 5 years)
- Number of Revisions as a Measure of Surgical Quality(3 months, 6 months, every year up to 5 years)
- Health-Related Quality of Life Score on the SF-12(3 months, 6 months, every year up to 5 years)
- Pain Score on the WOMAC(3 months, 6 months, every year up to 5 years)
- Stiffness Score on the WOMAC(3 months, 6 months, every year up to 5 years)
- Physical Function Score on the WOMAC(3 months, 6 months, every year up to 5 years)
- Activity Level Score on the UCLA Activity Index(3 months, 6 months, every year up to 5 years)