Femoral Neck FracturesNCT04375501
A Study of Outcomes in Patients With Fractured Neck of Femur During the COVID-19 Pandemic
An observational study of Femoral Neck Fractures and SARS-CoV 2, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
In early 2020 the evolving COVID-19 Pandemic provided the world and medical community with a generational challenge. As a novel disease, countries were left with strategic decisions and many went into social lockdown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Neck Fractures, SARS-CoV 2
- What is being tested?
- Surgery: Dynamic Hip Screw, hemiarthroplasty, hip replacement, intramedullary nail
- How many people
- 442 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2020to 15 Apr 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted February 1st 2020 to April 15th 2020 with fractured neck of femur
Who may be able to join
- Fractured neck of femur
- Received operative intervention for fractured neck of femur
Who cannot join
- open fracture
- fracture of femoral shaft
- periprosthetic fracture
- revision surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Coronavirus on Perioperative Morbidity and Mortality in a High-risk Population: A Multicentre Cohort Study
In early 2020 the evolving COVID-19 Pandemic provided the world and medical community with a generational challenge. As a novel disease, countries were left with strategic decisions and many went into social lockdown. Initial resources and research were directed at upscaling internal medicine and intensive care services, understanding the disease pathophysiology, and testing treatments. It soon became evident that COVID-19 had multi-system effects at it's worst. In orthopaedics one of the most vulnerable groups to COVID-19 were the elderly, specifically those who suffered fractured neck of femur at this time. More literature is needed urgently if we are to understand and mitigate the negative impacts in this group of patients. This observational study assesses the early morbidity and mortality of patients with this diagnosis during the evolving COVID-19 Pandemic.
Read the detailed description
Many elderly patients admitted to hospitals during the evolving COVID-19 pandemic after falls or being generally unwell, were considered to have a possible diagnosis of COVID-19. This was extremely relevant to the subgroup of patients who suffered from fractured neck of femurs during this time, with most of them elderly, frail, and more likely to have multiple co-morbidities. COVID-19 was considered a precipitating factor for falls, but also anecdotally, an indicator of potentially poor recovery and rehabilitation.
With regards to orthopaedic and trauma surgery, a limited amount of literature is available pertaining to COVID-19 and specifically it's potential effects on patient outcomes in patients requiring surgery.
We performed a multi centre observational study across London, United Kingdom, looking at the demographics and details of patients admitted with fractured neck of femur during the evolving pandemic. All data collected was non identifiable. Data was also collected as to the COVID-19 status of these patients, either positive or negative. Data was analysed to assess the morbidity and mortality of this patient group and search for any prognostic factors.
- Conditions
- Femoral Neck Fractures, SARS-CoV 2
- Being tested
- Surgery: Dynamic Hip Screw, hemiarthroplasty, hip replacement, intramedullary nail
- Keywords
- COVID-19, Coronavirus, Neck of femur, Morbidity, Mortality, Prognosis
- Medical subject headings
- Femoral Neck Fractures, COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery: Dynamic Hip Screw, hemiarthroplasty, hip replacement, intramedullary nailOther
If fit for anaesthesia patients may undergo relevant procedure for fractured neck of femur as per NICE guidelines within limitations of resources as defined by BOAST
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive | All patients admitted with fractured neck of femur during specified time period testing POSITIVE for COVID-19 Receives: Other: Surgery: Dynamic Hip Screw, hemiarthroplasty, hip replacement, intramedullary nail | |
| COVID-19 negative | All patients admitted with fractured neck of femur during specified time period testing NEGATIVE for COVID-19 Receives: Other: Surgery: Dynamic Hip Screw, hemiarthroplasty, hip replacement, intramedullary nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death
Measured: 30 day
Morbidity
Morbidity
Measured: 30 day
Secondary outcomes (1)
Discharge
Discharge to home, rehabilitation or community setting
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Feb 2020
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies 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
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals, Barking, Havering and Redbridge University Hospitals NHS Trust, Mid and South Essex NHS Foundation Trust, Frimley Park Hospital NHS Trust, The Hillingdon Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Elliot Onochie, Barts & The London NHS Trust
- Investigators
- Babar Kayani, MBBS, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375501
- Sponsor's protocol ID
- 284104
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Coronavirus on Perioperative Morbidity and Mortality in a High-risk Population: A Multicentre Cohort Study
- ClinicalTrials.gov ID
- NCT04375501
- Acronym / sponsor ID
- 284104
- Conditions
- Femoral Neck Fractures, SARS-CoV 2
- Keywords
- COVID-19, Coronavirus, Neck of femur, Morbidity, Mortality, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- University College London Hospitals, Barking, Havering and Redbridge University Hospitals NHS Trust, Mid and South Essex NHS Foundation Trust, Frimley Park Hospital NHS Trust, The Hillingdon Hospitals NHS Foundation Trust
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 5 May 2020 (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.
In early 2020 the evolving COVID-19 Pandemic provided the world and medical community with a generational challenge. As a novel disease, countries were left with strategic decisions and many went into social lockdown. Initial resources and research were directed at upscaling internal medicine and intensive care services, understanding the disease pathophysiology, and testing treatments. It soon became evident that COVID-19 had multi-system effects at it's worst. In orthopaedics one of the most vulnerable groups to COVID-19 were the elderly, specifically those who suffered fractured neck of femur at this time. More literature is needed urgently if we are to understand and mitigate the negative impacts in this group of patients. This observational study assesses the early morbidity and mortality of patients with this diagnosis during the evolving COVID-19 Pandemic.
Detailed description
Many elderly patients admitted to hospitals during the evolving COVID-19 pandemic after falls or being generally unwell, were considered to have a possible diagnosis of COVID-19. This was extremely relevant to the subgroup of patients who suffered from fractured neck of femurs during this time, with most of them elderly, frail, and more likely to have multiple co-morbidities. COVID-19 was considered a precipitating factor for falls, but also anecdotally, an indicator of potentially poor recovery and rehabilitation.
With regards to orthopaedic and trauma surgery, a limited amount of literature is available pertaining to COVID-19 and specifically it's potential effects on patient outcomes in patients requiring surgery.
We performed a multi centre observational study across London, United Kingdom, looking at the demographics and details of patients admitted with fractured neck of femur during the evolving pandemic. All data collected was non identifiable. Data was also collected as to the COVID-19 status of these patients, either positive or negative. Data was analysed to assess the morbidity and mortality of this patient group and search for any prognostic factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive | – | Other: Surgery: Dynamic Hip Screw, hemiarthroplasty, hip replacement, intramedullary nailAll patients admitted with fractured neck of femur during specified time period testing POSITIVE for COVID-19 |
| COVID-19 negative | – | Other: Surgery: Dynamic Hip Screw, hemiarthroplasty, hip replacement, intramedullary nailAll patients admitted with fractured neck of femur during specified time period testing NEGATIVE for COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted February 1st 2020 to April 15th 2020 with fractured neck of femur
Key inclusion criteria (2 listed)
- Fractured neck of femur
- Received operative intervention for fractured neck of femur
Key exclusion criteria (4 listed)
- open fracture
- fracture of femoral shaft
- periprosthetic fracture
- revision surgery
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 |
|---|---|---|
| Surgery: Dynamic Hip Screw, hemiarthroplasty, hip replacement, intramedullary nailIf fit for anaesthesia patients may undergo relevant procedure for fractured neck of femur as per NICE guidelines within limitations of resources as defined by BOAST | Other | COVID-19 negative, COVID-19 positive |
Primary outcome
Mortality
Time frame: 30 day
Death
Morbidity
Time frame: 30 day
Morbidity
1 secondary outcome
Discharge
Time frame: 30 day
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 20 May 2020.
- Individual participant dataSharing planned: No. No IPD will be shared
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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.
Babar Kayani, MBBS principal investigator
Barts & The London NHS Trust
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 Femoral Neck Fractures and SARS-CoV 2, run by Barts & The London 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 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 20 May 2020. 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?
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?
Mortality (time frame: 30 day). 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 20 May 2020.