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NCT Number: NCT04375501

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

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.

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Key information

Conditions

Femoral Neck Fractures COVID-19 Coronaviridae Infections Coronavirus Infections Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Infections Leg Injuries Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV 2 Virus Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barts Health NHS Trust

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

  1. Mortality

    Time frame: 30 day

    Death

  2. Morbidity

    Time frame: 30 day

    Morbidity

Secondary outcomes

  1. Discharge

    Time frame: 30 day

    Discharge to home, rehabilitation or community setting

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Collaborators

  • Barking, Havering and Redbridge University Hospitals NHS Trust
  • Frimley Park Hospital NHS Trust
  • Mid and South Essex NHS Foundation Trust
  • The Hillingdon Hospitals NHS Foundation Trust
  • University College London Hospitals

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 5, 2020
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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