MACE and PE in Elective Primary TKA & THA

Completed

• Conditions: Cardiovascular Complication; Transient Ischemic Attack; Stroke; Pulmonary Embolism; Death

• Registration Number: NCT05116280
• Lead Sponsor: University of Thessaly

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

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-01-30
• Status Verified: 2021-10
• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-29
• Last Update Submitted: 2021-10-29
• Study First Posted: 2021-11-11
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
Pulmonary Embolism	1month postoperatively	PE

Trial Locations

Locations (1)

University of Thessaly; 🇬🇷 Larissa, Greece