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C3 Total Joint Patient Registry

2014年7月10日 更新者：DC2 Healthcare

Clinical Care Continuum (C3) Total Joint Patient Registry

This study will assess the efficacy of products, implants, and procedures for knee and hip replacement.

研究概览

地位

未知

条件

详细说明

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.

研究类型

观察性的

注册 (预期的)

10000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Tennessee
      • Nashville、Tennessee、美国、37211

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study population will come from cohorts of patients undergoing either knee or hip replacement in accordance with a nationwide multicenter observational study design. Eligibility criteria require only that patients are undergoing knee or hip replacement, are able to sign informed consent and are 18 years of age or older. Approximately 10,000 patients will be enrolled

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Inability to complete follow-up visits or required questionnaires
  • Inability to provide informed consent without a legally authorized representative

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Knee Replacement
Patients undergoing knee replacement surgery
Hip Replacement
Patients undergoing hip replacement

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 3 months
大体时间：baseline and 3 months
Assessment of hip symptoms and disability to be taken at baseline and 3 months after surgery
baseline and 3 months
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 6 months
大体时间：baseline and 6 months
Assessment of hip symptoms and disability to be taken at baseline and 6 months after surgery
baseline and 6 months
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 1 year
大体时间：baseline and 1 year
Assessment of hip symptoms and disability to be taken at baseline and 1 year after surgery
baseline and 1 year
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 3 months
大体时间：baseline and 3 months
Assessment of knee symptoms and disability to be taken at baseline and 3 months after surgery
baseline and 3 months
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 1 year
大体时间：baseline and 1 year
Assessment of knee symptoms and disability to be taken at baseline and 1 year after surgery
baseline and 1 year
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 6 months
大体时间：baseline and 6 months
Assessment of knee symptoms and disability to be taken at baseline and 6 months after surgery
baseline and 6 months

次要结果测量

结果测量
措施说明
大体时间
Adverse Events at time of surgery
大体时间：Time of surgery
Time of surgery
Adverse Events at 6 weeks after surgery
大体时间：6 weeks after surgery
within 6 weeks but not less than 1 week after surgery
6 weeks after surgery
Adverse Events at 3 months after surgery
大体时间：3 months after surgery
3 months after surgery
Adverse Events at 6 months after surgery
大体时间：6 months after surgery
6 months after surgery
Adverse Events at 1 year after surgery
大体时间：1 year after surgery
1 year after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

DC2 Healthcare

合作者

National Research Independent Operations Management
Clinical Care Continuum (C3) Foundation

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年5月1日

初级完成 (预期的)

2016年12月1日

研究注册日期

首次提交

2014年7月10日

首先提交符合 QC 标准的

2014年7月10日

首次发布 (估计)

2014年7月11日

研究记录更新

最后更新发布 (估计)

2014年7月11日

上次提交的符合 QC 标准的更新

2014年7月10日

最后验证

2014年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • C3 1001

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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