Clinical trial NCT04375501: A Study of Outcomes in Patients With Fractured Neck of Femur During the COVID-19 Pandemic
Official title: The Effects of Coronavirus on Perioperative Morbidity and Mortality in a High-risk Population: A Multicentre Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Neck Fractures
SARS-CoV 2
Keywords: COVID-19
Coronavirus
Neck of femur
Morbidity
Mortality
Prognosis
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: University College London Hospitals
name: Barking, Havering and Redbridge University Hospitals NHS Trust
name: Mid and South Essex NHS Foundation Trust
name: Frimley Park Hospital NHS Trust
name: The Hillingdon Hospitals NHS Foundation Trust
First posted: 2020-05-05
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted February 1st 2020 to April 15th 2020 with fractured neck of femur

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Fractured neck of femur
* Received operative intervention for fractured neck of femur

Exclusion Criteria:

* open fracture
* fracture of femoral shaft
* periprosthetic fracture
* revision surgery

Primary outcomes:
measure: Mortality
timeFrame: 30 day
measure: Morbidity
timeFrame: 30 day
Secondary outcomes:
measure: Discharge
timeFrame: 30 day
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust
Study officials:
affiliation: Barts & The London NHS Trust
name: Babar Kayani, MBBS
role: PRINCIPAL_INVESTIGATOR
References: