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CompletedNCT04375501Updated May 20, 2020

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

An observational study in Femoral Neck Fractures and SARS-CoV 2, sponsored by Barts & The London NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-20.

Sponsored by Barts & The London NHS Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
442
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Femoral Neck Fractures
  • SARS-CoV 2

Keywords

  • COVID-19
  • Coronavirus
  • Neck of femur
  • Morbidity
  • Mortality
  • Prognosis
03

In context

Femoral Neck Fractures

204 studies on the registry are indexed under Femoral Neck Fractures; 41 are open to participants now.

This study's enrollment of 442 is above the median of 134 across 59 observational studies indexed under Femoral Neck Fractures.

Browse Femoral Neck Fractures studies →

Lead sponsor

Barts & The London NHS Trust is the lead sponsor of 149 studies on the registry; 21 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients admitted February 1st 2020 to April 15th 2020 with fractured neck of femur

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • open fracture
  • fracture of femoral shaft
  • periprosthetic fracture
  • revision surgery
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
442 participants (actual)
Patient registry
No

Groups and cohorts

  • COVID-19 positive

    All patients admitted with fractured neck of femur during specified time period testing POSITIVE for COVID-19

    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

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

Interventions

  • OtherSurgery: 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

06

What researchers measure

Primary outcomes

  1. Mortality

    Death

    Time frame: 30 day

  2. Morbidity

    Morbidity

    Time frame: 30 day

Secondary outcomes

  1. Discharge

    Discharge to home, rehabilitation or community setting

    Time frame: 30 day

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Study locations

1 site
  • Barts Health NHS Trust
    London, United Kingdom
08

References and documents

Individual participant data

Plan to share: No — No IPD will be shared

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04375501
Lead sponsor
Barts & The London NHS Trust
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
Elliot Onochie (Author and Investigator, Barts & The London NHS Trust) — Principal investigator
First posted
May 5, 2020
Start date
Feb 1, 2020
Primary completion
Apr 15, 2020
Completion
Apr 15, 2020
Last update
May 20, 2020

Study contacts

Babar Kayani, MBBS
principal investigator · Barts & The London NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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