Hip Fracture and COVID-19

NCT04944329 | Completed

• 1 other identifier: LOCAL/2021/PC-02
• Study Type: observational
• Target: 73,661
• Locations: 1 country
• Sites: 1

Brief Summary

Hip fracture in the elderly is a worldwide public health issue and a medical challenge for early postoperative rehabilitation. More than 2 million people are treated annually with an annual incidence between 100 and 300/100,000 (USA, Europe, China), resulting in a cost of billion dollars and a strain on most surgical facilities. In this context, an early surgical management of patient with fracture within the first 24-48h has been shown to reduce morbidity, length of hospital stay and mortality. During the Covid-19 pandemics, a higher risk of 30-day mortality has been reported in patients with pre-operative SARS-CoV-2 infection diagnosed 0-2 weeks, 3-4 weeks and 5-6 weeks before surgery compared with patients who did not have a pre-operative SARS-CoV-2 infection. However, this risk seems to disappear in patients diagnosed with SARS-CoV-2 ≥ 7 weeks before surgery. These findings led to propose delayed elective surgery when the benefit-risk ratio was acceptable (cancer, cardiac surgeries). However, delaying surgery in COVID-19 patients (with high risk of immune and thrombotic disorders) with hip fracture could be questionable as the risk related to COVID-19 could be counteracted by the risk delayed surgery. For assessing the mortality risk related to hip fracture surgery associated with COVID-19, we decided to use the French national hospital discharge records database for comparing the 30-day postoperative mortality in patients with hip fracture and with or without an hospitalization for SARS-COV-2 infection in the 30 previous days before surgery.

Conditions

SARS-CoV2 Infection; Hip Fractures; Surgery

Outcome Measures

Primary Outcomes (1)

• Hospital Mortality

  hospital mortality within 30 days of the date of hospital admission for hip fracture

  Day 0 to Day 30

Study Arms (1)

COLCOVID

adults undergoing hip fracture surgery

Procedure: Hip fracture surgery

Interventions

Hip fracture surgery PROCEDURE

Hip fracture surgery

COLCOVID

Eligibility Criteria

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

Study Population

Patients with hip fracture, and with or without a SARS-COV-2 disease: We included all patients older than 65 years with hip fracture hospitalization recorded between March 1, 2020 and December 31, detected through ICD-10 diagnosis codes , and with a DRG Codes (Diagnosis Related Group) indicating a surgical procedure. Patient with hip fracture hospitalization without a care code indicating a surgical procedure were excluded. Among these patients, we searched for hospitalizations with SARS-CoV2 diagnostic that occurred within 30 days before the date of hospital admission for hip fracture.

You may qualify if:

• Age \> 65 yars
• hip fracture hospitalization
• care code indicating a surgical procedure

You may not qualify if:

• Patient with hip fracture hospitalization without a care code indicating a surgical procedure

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de NIMES

Nîmes, 30029, France

Location

MeSH Terms

Conditions

COVID-19; Hip Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Philippe Cuvillon

  CHU NIMES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: June 29, 2021
• Study Start: March 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)