CJRR: California Joint Replacement Registry

Sponsor
California Joint Replacement Registry (Other)
Overall Status
Unknown status
CT.gov ID
NCT01787812
Collaborator
(none)
2,500
1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    California Joint Replacement Registry
    Study Start Date :
    Jul 1, 2011
    Anticipated Primary Completion Date :
    Dec 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Number of Patients with Total Hip Replacement [3 months, 6 months, every year up to 5 years]

    2. Number of Patients with Partial Hip Replacement [3 months, 6 months, every year up to 5 years]

    3. Number of Patients with Hip Revision [3 months, 6 months, every year up to 5 years]

    4. Number of Patients with Total Knee Replacement [3 months, 6 months, every year up to 5 years]

    5. Number of Patients with Knee Revision [3 months, 6 months, every year up to 5 years]

    Secondary Outcome Measures

    1. Number and Type of Adverse Events as a Measure of Patient Safety [3 months]

      Adverse Events: Would infection Fracture Excessive bleeding DVT proximal DVT PE Congestive heart Arrhythmia Renal failure Nerve injury MI

    2. Number and Type of Readmissions as a Measure of Surgical Quality [3 months, 6 months, every year up to 5 years]

    3. Number of Revisions as a Measure of Surgical Quality [3 months, 6 months, every year up to 5 years]

    4. Health-Related Quality of Life Score on the SF-12 [3 months, 6 months, every year up to 5 years]

    5. Pain Score on the WOMAC [3 months, 6 months, every year up to 5 years]

    6. Stiffness Score on the WOMAC [3 months, 6 months, every year up to 5 years]

    7. Physical Function Score on the WOMAC [3 months, 6 months, every year up to 5 years]

    8. Activity Level Score on the UCLA Activity Index [3 months, 6 months, every year up to 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Receiving hip or knee replacement surgery in California.
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hoag Orthopedic Institute Irvine California United States 92618

    Sponsors and Collaborators

    • California Joint Replacement Registry

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    California Joint Replacement Registry
    ClinicalTrials.gov Identifier:
    NCT01787812
    Other Study ID Numbers:
    • CJRR-2013
    First Posted:
    Feb 11, 2013
    Last Update Posted:
    Jul 4, 2013
    Last Verified:
    Jul 1, 2013

    Study Results

    No Results Posted as of Jul 4, 2013