Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04375501
Recruitment Status : Completed
First Posted : May 5, 2020
Last Update Posted : May 20, 2020
Sponsor:
Collaborators:
University College London Hospitals
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
Information provided by (Responsible Party):
Elliot Onochie, Barts & The London NHS Trust

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
Femoral Neck Fractures SARS-CoV 2 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.

Layout table for study information
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 : February 1, 2020
Actual Primary Completion Date : April 15, 2020
Actual Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 day ]
    Death

  2. Morbidity [ Time Frame: 30 day ]
    Morbidity


Secondary Outcome Measures :
  1. Discharge [ Time Frame: 30 day ]
    Discharge to home, rehabilitation or community setting



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04375501


Locations
Layout table for location information
United Kingdom
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
Basildon and Thurrock University Hospitals NHS Foundation Trust
Frimley Park Hospital NHS Trust
The Hillingdon Hospitals NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: Babar Kayani, MBBS Barts & The London NHS Trust
Layout table for additonal information
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    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elliot Onochie, Barts & The London NHS Trust:
COVID-19
Coronavirus
Neck of femur
Morbidity
Mortality
Prognosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries