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

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV 2; Femoral Neck Fractures
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 442

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Barts Health NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Death	30 day
Morbidity	Morbidity	30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discharge	Discharge to home, rehabilitation or community setting	30 day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): April 15, 2020
• Study Completion (Actual): April 15, 2020

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Prognosis; Coronavirus; COVID-19; Morbidity; Mortality; Neck of femur
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: 284104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No