HEJR: HealthEast Community Hip and Knee Replacement Registry

Sponsor
HealthEast Care System (Other)
Overall Status
Recruiting
CT.gov ID
NCT02692092
Collaborator
(none)
200,000
1
1199
166.8

Study Details

Study Description

Brief Summary

HealthEast Care System began the first community-based joint replacement registry (HJRR) in the U.S. in 1991, and now has more than 30,000 total joints registered. The purpose of the HJRR is to maintain and improve the care of individuals undergoing joint replacement surgery by providing timely information to their surgeons and the broader orthopaedic community.

As it moves into the third decade, the HJRR is proud of its role in the development of the national American Joint Replacement Registry (AJRR) and will remain an important contributor to the larger national effort in the advancement of orthopaedic science.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    HealthEast Care System began the first community-based joint replacement registry (HJRR) in the U.S. in 1991, with a database that allowed tracking of implant use and failure rates among the 90 orthopaedic surgeons performing arthroplasty surgery in the greater metropolitan area of St. Paul, MN. Initially conceived as part of a process to better manage costs and determine which implants were most cost-efficient, it became apparent that the registry would allow insight into the same process that had proven its value in the Scandinavian joint registries. With the knowledge that a majority of total joint arthroplasties in the U.S. are performed by relatively low-volume community surgeons, the HJRR remains uniquely positioned to reflect contemporary U.S. surgical practices.

    The purpose of the HJRR is to maintain and improve the care of individuals undergoing joint replacement surgery by providing timely information to their surgeons and the broader orthopaedic community. With the primary outcome measure of time to revision surgery, combined with analysis of confounding factors and mortality monitoring, the HJRR can provide some realistic measure of the success of a given arthroplasty procedure in our community. In addition, the registry can evaluate the relative effectiveness of different prosthetic designs, identify patient variables that may impact implant survival, and provide the tracking mechanism necessary in the event of implant recalls.

    Over the 20 years of its existence, the HJRR has refined its data-gathering, data verification, and data analysis and utilizes a process design that requires no direct surgeon involvement with data input. Volunteer surgeons review each revision chart and operative note to carefully delineate the reason for revision. The HJRR capture process has been validated and more than 94% of the revision surgery is performed within the HJRR. The database is used to generate information of practical use to the surgeon, and has been demonstrated to influence surgeon behavior. Among other examples, HJRR reports on the failure rates associated with unicompartmental knee arthroplasty, hybrid and cementless total knee arthroplasty, and metal-on-metal total hip designs have led to significant declines in their respective use over the periods documented. Similarly, the HJRR allowed for rapid notification of surgeons and expedited patient care during the three significant hip implant recalls of the last decade.

    As it moves into the third decade, the HJRR is proud of its influential role in the development of the national American Joint Replacement Registry (AJRR) as one of the earliest participants and pilot hospitals. It will remain an important contributor to the larger national effort, particularly for certain data subsets that may be outside of the scope of the much larger AJRR. The HJRR core workgroup has published widely on its findings in the last two decades, and looks forward to the future as a compelling example of how worthwhile information and advancements in orthopaedic science can be made in the community setting.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    200000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    HealthEast Community Hip and Knee Replacement Registry
    Study Start Date :
    Sep 1, 1991
    Anticipated Primary Completion Date :
    Aug 1, 2091
    Anticipated Study Completion Date :
    Aug 1, 2091

    Arms and Interventions

    Arm Intervention/Treatment
    Total Arthroplasty Patients

    Any patient who has received a total hip or total knee arthroplasty at a healtheast acute care hospital.

    Outcome Measures

    Primary Outcome Measures

    1. Cumulative Revision Rate [10 Years]

      Our end point of interest was revision for any reason, with revision defined as removal, exchange, or addition of components, requiring a second surgery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Total Hip or Total Knee Arthroplasty

    • HealthEast acute care hospital

    Exclusion Criteria:
    • Age<18

    • Primary procedure not performed at a HealthEast hospital

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HealthEast Care System Saint Paul Minnesota United States 55104

    Sponsors and Collaborators

    • HealthEast Care System

    Investigators

    • Principal Investigator: Terence J Gioe, MD, HealthEast Care System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HealthEast Care System
    ClinicalTrials.gov Identifier:
    NCT02692092
    Other Study ID Numbers:
    • 03 12 007R
    First Posted:
    Feb 25, 2016
    Last Update Posted:
    Feb 26, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by HealthEast Care System
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 26, 2018