TraumaNCT06237023
The Impact of the Covid-19 Pandemic on Orthopedic Trauma Management
A study testing epidemyolojical in people with Trauma and COVID-19 Pandemic, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma, COVID-19 Pandemic
- What is being tested?
- epidemyolojical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57,635 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients who were admitted between March 2019 and March 2021
- Patients presenting due to trauma
Who cannot join
- Patients Admitted Before the Pandemic and Outside the Pandemic Period
- Consultation or Outpatient Clinic Patients
- Non-Traumatic Conditions
- Patients with Incomplete Records
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Hamidiye Medical School, Bakırköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology
Istanbul
About this study
Official title: The Impact of the Covid-19 Pandemic on Orthopedic Trauma Management; a Cross-sectional Study
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.
Read the detailed description
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. For this purpose, an epidemiological study was conducted in our country, comparing trauma admissions to a level 1 trauma hospital during a one-year period before the pandemic with those in the year following the onset of the pandemic.Demographic characteristics of the patients, such as age and gender, were recorded. In addition, the injury mechanisms of the patients, diagnosis, injured extremityor anatomical region, broken bone, fracture classification, multitrauma rates, trauma releated complications, hospitalization days, and treatment modalities were examined.
- Conditions
- Trauma, COVID-19 Pandemic
- Being tested
- epidemyolojical
- Medical subject headings
- Wounds and Injuries, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidemyolojicalOther
Also called Epidemiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: epidemyolojical |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 6 months
Secondary outcomes (7)
Changes in Patient Demographic Characteristics
Changes in the age and gender distribution of patients before the pandemic and during the pandemic period.
Measured: 6 weeks
Comparison of Injury Mechanisms and Diagnoses
Different injury mechanisms and diagnosis distributions during the pandemic period compared to before the pandemic.
Measured: 8 weeks
Injured Extremities or Anatomical Regions
The extremities or anatomical regions that were most frequently injured before and during the pandemic period.
Measured: 8 weeks
Fracture Types and Classifications
Changes in fracture types and classifications during the pandemic period.
Measured: 6 weeks
Trauma-Related Complications
Changes in trauma-related complication rates before the pandemic and during the pandemic period.
Measured: 6 months
Treatment Methods
Changes in the treatment methods applied before the pandemic and during the pandemic period, especially the increases in surgical treatment rates.
Measured: 8 weeks
Length of Hospital Stay
Differences in average length of hospital stay before the pandemic and during the pandemic period.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Mar 2019
- Primary completion31 Mar 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 57,635 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vedat Öztürk, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237023
- Sponsor's protocol ID
- 2021-168
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Covid-19 Pandemic on Orthopedic Trauma Management; a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06237023
- Acronym / sponsor ID
- 2021-168
- Conditions
- Trauma, COVID-19 Pandemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57,635 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. For this purpose, an epidemiological study was conducted in our country, comparing trauma admissions to a level 1 trauma hospital during a one-year period before the pandemic with those in the year following the onset of the pandemic.Demographic characteristics of the patients, such as age and gender, were recorded. In addition, the injury mechanisms of the patients, diagnosis, injured extremityor anatomical region, broken bone, fracture classification, multitrauma rates, trauma releated complications, hospitalization days, and treatment modalities were examined.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-pandemic group | Other | Other: epidemyolojicalPatients who presented to the Orthopedics and Traumatology unit for any trauma-related reason during the one-year period prior to the pandemic |
| post-pandemic group | Other | Other: epidemyolojicalPatients who presented to the Orthopedics and Traumatology unit for any trauma-related reason within one year from the start of the pandemic |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The patients who were admitted between March 2019 and March 2021
- Patients presenting due to trauma
Key exclusion criteria (4 listed)
- Patients Admitted Before the Pandemic and Outside the Pandemic Period
- Consultation or Outpatient Clinic Patients
- Non-Traumatic Conditions
- Patients with Incomplete Records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidemyolojicalAlso: EpidemiologicalThe 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. | Other | post-pandemic group, pre-pandemic group |
Primary outcome
Comparison of Emergency Orthopedic Trauma Admissions Between Pre-Pandemic and Pandemic Period
Time frame: up to 6 months
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.
Detection of Changes in the Epidemiology of Orthopedic Trauma
Time frame: up to 6 months
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.
7 secondary outcomes
Changes in Patient Demographic Characteristics
Time frame: 6 weeks
Comparison of Injury Mechanisms and Diagnoses
Time frame: 8 weeks
Injured Extremities or Anatomical Regions
Time frame: 8 weeks
Fracture Types and Classifications
Time frame: 6 weeks
Trauma-Related Complications
Time frame: 6 months
Treatment Methods
Time frame: 8 weeks
Length of Hospital Stay
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Trauma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidemyolojical in people with Trauma and COVID-19 Pandemic, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Emergency Orthopedic Trauma Admissions Between Pre-Pandemic and Pandemic Period (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.