Clinical trial NCT04944329: Hip Fracture and COVID-19
Official title: Association Between Covid-19 Disease and Mortality After Hip Fracture Surgery in Elderly: a Multicentre National French Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2 Infection
Hip Fractures
Surgery
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 73661
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Hospital Mortality
timeFrame: Day 0 to Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU de NIMES
Study officials:
affiliation: CHU NIMES
name: Philippe Cuvillon
role: PRINCIPAL_INVESTIGATOR
References: