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

NCT04375501 | Completed

• 1 other identifier: 284104
• Study Type: observational
• Target: 442
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Neck Fractures; SARS-CoV 2

Keywords

COVID-19; Coronavirus; Neck of femur; Morbidity; Mortality; Prognosis

Outcome Measures

Primary Outcomes (2)

• Mortality

  Death

  30 day

• Morbidity

  Morbidity

  30 day

Secondary Outcomes (1)

• Discharge

  30 day

Study Arms (2)

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

Surgery: Dynamic Hip Screw, hemiarthroplasty, hip replacement, intramedullary nail 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; COVID-19 positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• University College London Hospitals: collaborator
• Barking, Havering and Redbridge University Hospitals NHS Trust: collaborator
• Mid and South Essex NHS Foundation Trust: collaborator
• Frimley Park Hospital NHS Trust: collaborator
• The Hillingdon Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Barts Health NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Femoral Neck Fractures; COVID-19; Coronavirus Infections

Interventions

Hemiarthroplasty; Arthroplasty, Replacement, Hip; Fracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Fracture Fixation, Internal; Fracture Fixation; Therapeutics

Study Officials

• Babar Kayani, MBBS

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Author and Investigator

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 5, 2020
• Study Start: February 1, 2020
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)