Clinical trial NCT01787812: California Joint Replacement Registry
Official title: California Joint Replacement Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip and Knee Replacement Surgeries
Lead sponsor: California Joint Replacement Registry
Sponsor class: NETWORK
First posted: 2013-02-11
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Californians, 18+ years of age, receiving hip or knee replacement surgery in California.

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).


Eligibility criteria: Inclusion Criteria:

* Receiving hip or knee replacement surgery in California.

Exclusion Criteria:

-

Primary outcomes:
measure: Number of Patients with Total Hip Replacement
timeFrame: 3 months, 6 months, every year up to 5 years
measure: Number of Patients with Partial Hip Replacement
timeFrame: 3 months, 6 months, every year up to 5 years
measure: Number of Patients with Hip Revision
timeFrame: 3 months, 6 months, every year up to 5 years
measure: Number of Patients with Total Knee Replacement
timeFrame: 3 months, 6 months, every year up to 5 years
measure: Number of Patients with Knee Revision
timeFrame: 3 months, 6 months, every year up to 5 years
Secondary outcomes:
measure: Number and Type of Adverse Events as a Measure of Patient Safety
timeFrame: 3 months
measure: Number and Type of Readmissions as a Measure of Surgical Quality
timeFrame: 3 months, 6 months, every year up to 5 years
measure: Number of Revisions as a Measure of Surgical Quality
timeFrame: 3 months, 6 months, every year up to 5 years
measure: Health-Related Quality of Life Score on the SF-12
timeFrame: 3 months, 6 months, every year up to 5 years
measure: Pain Score on the WOMAC
timeFrame: 3 months, 6 months, every year up to 5 years
measure: Stiffness Score on the WOMAC
timeFrame: 3 months, 6 months, every year up to 5 years
measure: Physical Function Score on the WOMAC
timeFrame: 3 months, 6 months, every year up to 5 years
measure: Activity Level Score on the UCLA Activity Index
timeFrame: 3 months, 6 months, every year up to 5 years
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Hoag Orthopedic Institute
state: California
Study officials:
References: