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Completed

NCT Number: NCT05116280

MACE and PE in Elective Primary TKA & THA

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

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Key information

Conditions

Cardiovascular Complication Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Death Embolism Embolism and Thrombosis Ischemic Attack, Transient Lung Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Respiratory Tract Diseases Stroke Transient Ischemic Attack Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Thessaly

Larissa, 41335, Greece

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Major Adverse Cardiovascular Events

    Time frame: 1month postoperatively

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

  2. Pulmonary Embolism

    Time frame: 1month postoperatively

    PE

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

Registration of the Major Adverse Cardiovascular Events and Pulmonary Embolism in Primary Total Joint Arthroplasty

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Nov 11, 2021
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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