A Study of Outcomes in Patients With Fractured Neck of Femur During the COVID-19 Pandemic

SARS-CoV 2 Clinical Trial

Official title:

The Effects of Coronavirus on Perioperative Morbidity and Mortality in a High-risk Population: A Multicentre Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04375501
• Other study ID #: 284104
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: April 15, 2020

Study information

• Verified date: May 2020
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neck Fractures
• SARS-CoV 2

Intervention

Other:
• Surgery: Dynamic Hip Screw, hemiarthroplasty, hip replacement, intramedullary nail
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

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust	London

Sponsors (6)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	Barking, Havering and Redbridge University Hospitals NHS Trust, Basildon and Thurrock University Hospitals NHS Foundation Trust, Frimley Park Hospital NHS Trust, The Hillingdon Hospitals NHS Foundation Trust, University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death	30 day
Primary	Morbidity	Morbidity	30 day
Secondary	Discharge	Discharge to home, rehabilitation or community setting	30 day