MACE and PE in Elective Primary TKA & THA | NCT05116280

Studies
MACE and PE in Elective Primary TKA & THA

NCT05116280

Sponsor

University of Thessaly

Status

Completed

Last Update Posted

Nov 11, 2021Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Cardiovascular Complication
Pulmonary Embolism
Stroke
Transient Ischemic Attack
Death

Interventions

Not provided

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Jan 30, 2019Actual

First Submitted Date

Oct 5, 2021

First Submission Date that Met QC Criteria

Oct 29, 2021

First Posted Date

Nov 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2021

Last Update Posted Date

Nov 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major Adverse Cardiovascular Events	MACE (non-fatal-cardiac arrest, acute myocardial infraction, congestive cardiac failure, cardiac arrhythmia, angina, stroke, cardiovascular death, cerebrovascular, death)	1month postoperatively
Pulmonary Embolism	PE	1month postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Thessaly		Larissa		41335	Greece

Condition Browse Module

MeSH Terms

ID	Term
D011655	Pulmonary Embolism
D020521	Stroke
D002546	Ischemic Attack, Transient
D003643	Death

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis

Browse Leaves

Not provided

Browse Branches

Not provided