- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01787812
California Joint Replacement Registry (CJRR)
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).
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
California
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Irvine, California, United States, 92618
- Recruiting
- Hoag Orthopedic Institute
-
Contact:
- Kanoelani Allen, MSN-CNS, PHN, RN
- Phone Number: 949.517.3138
- Email: kallen@hoag.org
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Principal Investigator:
- James Caillouette, M.D.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Receiving hip or knee replacement surgery in California.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Patients with Total Hip Replacement
Time Frame: 3 months, 6 months, every year up to 5 years
|
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
|
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
|
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
|
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
|
3 months, 6 months, every year up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number and Type of Adverse Events as a Measure of Patient Safety
Time Frame: 3 months
|
Adverse Events:
|
3 months
|
|
Number and Type of Readmissions as a Measure of Surgical Quality
Time Frame: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
|
Number of Revisions as a Measure of Surgical Quality
Time Frame: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
|
Health-Related Quality of Life Score on the SF-12
Time Frame: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
|
Pain Score on the WOMAC
Time Frame: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
|
Stiffness Score on the WOMAC
Time Frame: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
|
Physical Function Score on the WOMAC
Time Frame: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
|
Activity Level Score on the UCLA Activity Index
Time Frame: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CJRR-2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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