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

NCT ID: NCT04375501

Last Updated: 2020-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

442 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-04-15

Brief Summary

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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

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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

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Femoral Neck Fractures SARS-CoV 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 positive

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

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

Intervention Type 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

COVID-19 negative

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

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

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College London Hospitals

OTHER

Sponsor Role collaborator

Barking, Havering and Redbridge University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Mid and South Essex NHS Foundation Trust

OTHER

Sponsor Role collaborator

Frimley Park Hospital NHS Trust

OTHER

Sponsor Role collaborator

The Hillingdon Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

Barts & The London NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Elliot Onochie

Author and Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Babar Kayani, MBBS

Role: PRINCIPAL_INVESTIGATOR

Barts & The London NHS Trust

Locations

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Barts Health NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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284104

Identifier Type: -

Identifier Source: org_study_id

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