Hip Fracture and COVID-19

Surgery Clinical Trial

— COLCOVID  

Official title:

Association Between Covid-19 Disease and Mortality After Hip Fracture Surgery in Elderly: a Multicentre National French Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04944329
• Other study ID #: LOCAL/2021/PC-02
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73661
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• SARS-CoV2 Infection
• Surgery

Intervention

Procedure:
• Hip fracture surgery
Hip fracture surgery

Locations

Country	Name	City	State
France	CHU de NIMES	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Mortality	hospital mortality within 30 days of the date of hospital admission for hip fracture	Day 0 to Day 30