Covid19COVERTNCT05026788
Impact of COVID-19 Pandemic on Orthopaedic Practice
An observational study of Covid19 and Trauma, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19, Trauma, Orthopedic Disorder
- What is being tested?
- type of treatment
- How many people
- 5,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Mar 2020to 30 Apr 2022
- Phase
- Observational
- 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
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.
Who may be able to join
- anyone presenting with orthopaedic trauma to the Emergency Department who has been referred to the on-call Trauma and Orthopaedic team for further management.
Who cannot join
- spinal trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, Trauma, Orthopedic Disorder, Anesthesia, Morality
- Being tested
- type of treatment
- Medical subject headings
- COVID-19, Wounds and Injuries, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
type of treatmentOther
pathway of management for conservative treatment, operative treatment and type of anaesthesia used
| Study group | Role | What they receive |
|---|---|---|
| Intra-COVID lockdown | Any patients treated for orthopaedic trauma within the mandatory lockdown due to the pandemic. Receives: Other: type of treatment | |
| Pre/post-COVID lockdown | Any patients treated for orthopaedic trauma either before or after the imposition of lockdown induced by the pandemic. Receives: Other: type of treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment
Non-operative vs operative management
Measured: duration of study
Mortality rate
For patients presenting with orthopaedic trauma
Measured: duration of study
Number of COVID positive patients
For patients presenting with orthopaedic trauma regardless of treatment pathway
Measured: duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start17 Mar 2020
- Primary completion30 Apr 2020
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kapil Sugand, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026788
- Sponsor's protocol ID
- 1414607
- Acronym
- COVERT
- Status last verified
- Oct 2021
- First submitted
- 26 Aug 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any data will be published in academic journals
Publications
Park C, Sugand K, Nathwani D, Bhattacharya R, Sarraf KM. Impact of the COVID-19 pandemic on orthopedic trauma workload in a London level 1 trauma center: the "golden month". Acta Orthop. 2020 Oct;91(5):556-561. doi: 10.1080/17453674.2020.1783621. Epub 2020 Jun 23.
PubMed 32573331
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 Pandemic on Orthopaedic Practice: the COVid-19 Emergency/Elective Related Trauma (COVERT) Collaborative
- ClinicalTrials.gov ID
- NCT05026788
- Acronym / sponsor ID
- COVERT / 1414607
- Conditions
- Covid19, Trauma, Orthopedic Disorder, Anesthesia, Morality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 30 Aug 2021 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-COVID lockdown | – | Other: type of treatmentAny patients treated for orthopaedic trauma within the mandatory lockdown due to the pandemic. |
| Pre/post-COVID lockdown | – | Other: type of treatmentAny patients treated for orthopaedic trauma either before or after the imposition of lockdown induced by the pandemic. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- anyone presenting with orthopaedic trauma to the Emergency Department who has been referred to the on-call Trauma and Orthopaedic team for further management.
Key exclusion criteria (1 listed)
- spinal trauma
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 |
|---|---|---|
| type of treatmentpathway of management for conservative treatment, operative treatment and type of anaesthesia used | Other | Intra-COVID lockdown, Pre/post-COVID lockdown |
Primary outcome
Treatment
Time frame: duration of study
Non-operative vs operative management
Mortality rate
Time frame: duration of study
For patients presenting with orthopaedic trauma
Number of COVID positive patients
Time frame: duration of study
For patients presenting with orthopaedic trauma regardless of treatment pathway
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Results publication: PubMed 32573331Park C, Sugand K, Nathwani D, Bhattacharya R, Sarraf KM. Impact of the COVID-19 pandemic on orthopedic trauma workload in a London level 1 trauma center: the "golden month". Acta Orthop. 2020 Oct;91(5):556-561. doi: 10.1080/17453674.2020.1783621. Epub 2020 Jun 23.
- Individual participant dataSharing planned: No. Any data will be published in academic journals
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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?
An observational study of Covid19 and Trauma, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Oct 2021. 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 United Kingdom. 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?
Results are not available in the source record.
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?
Treatment (time frame: duration of study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05026788, which also lists 1 linked publication.
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 18 Oct 2021.