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Clinical Trials/NCT01787812
NCT01787812
Unknown
Not Applicable

California Joint Replacement Registry

California Joint Replacement Registry1 site in 1 country2,500 target enrollmentJuly 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip and Knee Replacement Surgeries
Sponsor
California Joint Replacement Registry
Enrollment
2500
Locations
1
Primary Endpoint
Number of Patients with Total Hip Replacement
Last Updated
12 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
December 2014
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
California Joint Replacement Registry
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Receiving hip or knee replacement surgery in California.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of Patients with Total Hip Replacement

Time Frame: 3 months, 6 months, every year up to 5 years

Number of Patients with Partial Hip Replacement

Time Frame: 3 months, 6 months, every year up to 5 years

Number of Patients with Hip Revision

Time Frame: 3 months, 6 months, every year up to 5 years

Number of Patients with Total Knee Replacement

Time Frame: 3 months, 6 months, every year up to 5 years

Number of Patients with Knee Revision

Time Frame: 3 months, 6 months, every year up to 5 years

Secondary Outcomes

  • 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)

Study Sites (1)

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