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MACE and PE in Elective Primary TKA & THA

Sponsor
University of Thessaly (Other)
Overall Status
Completed
CT.gov ID
NCT05116280
Collaborator
(none)
200
Enrollment
1
Location
12.9
Actual Duration (Months)
15.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study ought to identify the occurence of the major adverse cardiovascular events (MACE) and the pumonary emoblism (PE) in patients undergoing elective primary THA & TKA

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study included 220 consecutive patients undergoing elective primary THA & TKA from January 2018 to December 2018. The occcurence of major adverse cardiovascular events (MACE) and the pumonary emoblism (PE) were recorder. Under the term MACE the following were included; non fatal cardiac arrest acute myocardial infraction congestive cardiac failure cardiac arrhythmia agnina stroke cardiovascular death cerebrovascular death

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Registration of the Major Adverse Cardiovascular Events and Pulmonary Embolism in Primary Total Joint Arthroplasty
    Actual Study Start Date :
    Jan 1, 2018
    Actual Primary Completion Date :
    Dec 31, 2018
    Actual Study Completion Date :
    Jan 30, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    TJA

    patients with primary osteoarthritis of the knee and hip who underwent elective primary total hip and total knee arthroplasty. MACE and pulmonary embolism were recorded

    Outcome Measures

    Primary Outcome Measures

    1. Major Adverse Cardiovascular Events [1month postoperatively]

      MACE (non-fatal-cardiac arrest, acute myocardial infraction, congestive cardiac failure, cardiac arrhythmia, angina, stroke, cardiovascular death, cerebrovascular, death)

    2. Pulmonary Embolism [1month postoperatively]

      PE

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All consecutive patients age 18 years or older, with a diagnosis of primary osteoarthritis of the hip or knee, who underwent elective, primary, unilateral TKA or THA.
    Exclusion Criteria:

    • previous TKA or THA within 3 months

    • Revision surgery

    • Surgical procedures related to a previous complication

    • ASA PS IV

    • recent history (6 months) of unstable acute coronary syndrome or decompensated heart failure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Thessaly Larissa Greece 41335

    Sponsors and Collaborators

    • University of Thessaly

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elena Arnaoutoglou, Professor of Anesthesiology, University of Thessaly
    ClinicalTrials.gov Identifier:
    NCT05116280
    Other Study ID Numbers:
    • MACE & PE in TJA
    First Posted:
    Nov 11, 2021
    Last Update Posted:
    Nov 11, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Elena Arnaoutoglou, Professor of Anesthesiology, University of Thessaly
    total joint arthroplasty
    total hip arthroplasty
    total knee arthroplasty
    major adverse cardiovascular events
    pulmonary embolism
    Additional relevant MeSH terms:
    Pulmonary Embolism
    Ischemic Attack, Transient
    Embolism

    Study Results

    No Results Posted as of Nov 11, 2021