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CompletedNCT05116280Updated Nov 11, 2021

MACE and PE in Elective Primary TKA & THA

An observational study in Cardiovascular Complication, Pulmonary Embolism and Stroke, sponsored by University of Thessaly. Completed at 1 site in Greece. Per ClinicalTrials.gov, last updated 2021-11-11.

Sponsored by University of Thessaly · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Cardiovascular Complication
  • Pulmonary Embolism
  • Stroke
  • Transient Ischemic Attack
  • Death

Keywords

  • total joint arthroplasty
  • total hip arthroplasty
  • total knee arthroplasty
  • major adverse cardiovascular events
  • pulmonary embolism
03

In context

Pulmonary Embolism

739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.

This study's enrollment of 200 is below the median of 392 across 324 observational studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

University of Thessaly is the lead sponsor of 188 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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. Operations were performed by the 4 chief arthroplasty surgeons of the department.

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Major Adverse Cardiovascular Events

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

    Time frame: 1month postoperatively

  2. Pulmonary Embolism

    PE

    Time frame: 1month postoperatively

07

Study locations

1 site
  • University of Thessaly
    Larissa, 41335, Greece
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05116280
Lead sponsor
University of Thessaly
Responsible party
Elena Arnaoutoglou (Professor of Anesthesiology, University of Thessaly) — Principal investigator
First posted
Nov 11, 2021
Start date
Jan 1, 2018
Primary completion
Dec 31, 2018
Completion
Jan 30, 2019
Last update
Nov 11, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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