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

Sponsor
Barts & The London NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT04375501
Collaborator
University College London Hospitals (Other), Barking, Havering and Redbridge University Hospitals NHS Trust (Other), Mid and South Essex NHS Foundation Trust (Other), Frimley Park Hospital NHS Trust (Other), The Hillingdon Hospitals NHS Foundation Trust (Other)
442
1
2.4
181.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Surgery: Dynamic Hip Screw, hemiarthroplasty, hip replacement, intramedullary nail

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.

Study Design

Study Type:
Observational
Actual Enrollment :
442 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effects of Coronavirus on Perioperative Morbidity and Mortality in a High-risk Population: A Multicentre Cohort Study
Actual Study Start Date :
Feb 1, 2020
Actual Primary Completion Date :
Apr 15, 2020
Actual Study Completion Date :
Apr 15, 2020

Arms and Interventions

Arm Intervention/Treatment
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
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

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

Outcome Measures

Primary Outcome Measures

  1. Mortality [30 day]

    Death

  2. Morbidity [30 day]

    Morbidity

Secondary Outcome Measures

  1. Discharge [30 day]

    Discharge to home, rehabilitation or community setting

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Barts Health NHS Trust London United Kingdom

Sponsors and Collaborators

  • Barts & The London NHS Trust
  • 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

Investigators

  • Principal Investigator: Babar Kayani, MBBS, Barts & The London NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elliot Onochie, Author and Investigator, Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT04375501
Other Study ID Numbers:
  • 284104
First Posted:
May 5, 2020
Last Update Posted:
May 20, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elliot Onochie, Author and Investigator, Barts & The London NHS Trust
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 20, 2020