- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05026788
Impact of COVID-19 Pandemic on Orthopaedic Practice (COVERT)
October 9, 2021 updated by: Kapil Sugand, Imperial College Healthcare NHS Trust
Impact of COVID-19 Pandemic on Orthopaedic Practice: the COVid-19 Emergency/Elective Related Trauma (COVERT) Collaborative
The COVERT Collaborative is led by a group of academic surgeons that is looking into the impact of the unprecedented COVID-19 pandemic on Trauma and Orthopaedic practice.
This will involve both trauma and elective procedures, as well as mortality rates, operative and anaesthetic case mix.
The information will help to shape service reconfiguration and enhance patient-specific treatment especially in the threat of potential subsequent waves and future pandemics.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
In response to the health crisis, it is the responsibility of clinicians to audit and collaborate in order to observe the impact of the pandemic on clinical practice.
With the restructure of the health infrastructure, there is likely to be changes to the nature of acute referrals to Trauma and Orthopaedics, operative and anaesthetic casemix, polytrauma and open fractures as well as the role of technology to reduce viral transmission.
Patient safety ought to be prioritised at all times but a national narrative is required to equip healthcare services to counter the pandemic at various time intervals post-social distancing and lockdown at 1.5, 3, 6, 12, 18 and 24 months.
This will act as an audit to compare and contrast if the reconfiguration of healthcare services is abiding by the governmental, DoH, NHS, WHO, RCS and BOA (BOAST) policies and guidelines.
Study Type
Observational
Enrollment (Anticipated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom
- Imperial College Healthcare NHS Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Anyone presenting with orthopaedic trauma to the Emergency Department who has been referred to the on-call Trauma and Orthopaedic team for further management.
Description
Inclusion Criteria:
- anyone presenting with orthopaedic trauma to the Emergency Department who has been referred to the on-call Trauma and Orthopaedic team for further management.
Exclusion Criteria:
- spinal trauma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intra-COVID lockdown
Any patients treated for orthopaedic trauma within the mandatory lockdown due to the pandemic.
|
pathway of management for conservative treatment, operative treatment and type of anaesthesia used
|
Pre/post-COVID lockdown
Any patients treated for orthopaedic trauma either before or after the imposition of lockdown induced by the pandemic.
|
pathway of management for conservative treatment, operative treatment and type of anaesthesia used
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment
Time Frame: duration of study
|
Non-operative vs operative management
|
duration of study
|
Mortality rate
Time Frame: duration of study
|
For patients presenting with orthopaedic trauma
|
duration of study
|
Number of COVID positive patients
Time Frame: duration of study
|
For patients presenting with orthopaedic trauma regardless of treatment pathway
|
duration of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 17, 2020
Primary Completion (Actual)
April 30, 2020
Study Completion (Anticipated)
April 30, 2022
Study Registration Dates
First Submitted
August 26, 2021
First Submitted That Met QC Criteria
August 26, 2021
First Posted (Actual)
August 30, 2021
Study Record Updates
Last Update Posted (Actual)
October 18, 2021
Last Update Submitted That Met QC Criteria
October 9, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1414607
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Any data will be published in academic journals
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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