Viewing Study NCT01787812


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Study NCT ID: NCT01787812
Status: None
Last Update Posted: 2013-07-04 00:00:00
First Post: 2013-02-01 00:00:00
Is Possible Gene Therapy: False
Has Adverse Events: False

Brief Title: California Joint Replacement Registry
Sponsor: None
Organization:

Study Overview

Official Title: California Joint Replacement Registry
Status: None
Status Verified Date: 2013-07
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CJRR
Brief Summary: 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).
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: