NCT06237023

Brief Summary

The aim of the study is to compare emergency orthopedic trauma admissions between the pre-pandemic period and the pandemic period and to detect changes in orthopedic trauma epidemiology.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57,635

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

2.1 years

First QC Date

January 30, 2024

Last Update Submit

January 31, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Comparison of Emergency Orthopedic Trauma Admissions Between Pre-Pandemic and Pandemic Period

    The main purpose of the study is to compare the changes in the number and quality of emergency orthopedic trauma applications before the COVID-19 pandemic and during the pandemic period.

    up to 6 months

  • Detection of Changes in the Epidemiology of Orthopedic Trauma

    The research aims to determine the changes in the epidemiology of orthopedic traumas during the pandemic period compared to before the pandemic. This includes patient demographics, injury mechanisms, diagnoses, injured extremity or anatomical sites, fracture types and classifications, polytrauma rates, trauma-related complications, length of hospital stay, and treatment methods.

    up to 6 months

Secondary Outcomes (7)

  • Changes in Patient Demographic Characteristics

    6 weeks

  • Comparison of Injury Mechanisms and Diagnoses

    8 weeks

  • Injured Extremities or Anatomical Regions

    8 weeks

  • Fracture Types and Classifications

    6 weeks

  • Trauma-Related Complications

    6 months

  • +2 more secondary outcomes

Study Arms (2)

pre-pandemic group

OTHER

Patients who presented to the Orthopedics and Traumatology unit for any trauma-related reason during the one-year period prior to the pandemic

Other: epidemyolojical

post-pandemic group

OTHER

Patients who presented to the Orthopedics and Traumatology unit for any trauma-related reason within one year from the start of the pandemic

Other: epidemyolojical

Interventions

The aim of the study is to compare emergency orthopedic trauma admissions between the pre-pandemic and pandemic periods, and to identify changes in the epidemiology of orthopedic trauma.

Also known as: Epidemiological
post-pandemic grouppre-pandemic group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who were admitted between March 2019 and March 2021
  • Patients presenting due to trauma

You may not qualify if:

  • Patients Admitted Before the Pandemic and Outside the Pandemic Period
  • Consultation or Outpatient Clinic Patients
  • Non-Traumatic Conditions
  • Patients with Incomplete Records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Hamidiye Medical School, Bakırköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wounds and InjuriesCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 1, 2024

Study Start

March 1, 2019

Primary Completion

March 31, 2021

Study Completion

November 1, 2021

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations