COLCOVID: Hip Fracture and COVID-19

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Completed
• CT.gov ID: NCT04944329
• Collaborator: (none)
• Enrollment: 73,661
• Location: 1
• Actual Duration (Months): 10
• Patients Per Site Per Month: 7351

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV2 Infection; Hip Fractures; Surgery	Procedure: Hip fracture surgery

Study Design

• Study Type: Observational
• Actual Enrollment: 73661 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Association Between Covid-19 Disease and Mortality After Hip Fracture Surgery in Elderly: a Multicentre National French Survey
• Actual Study Start Date: Mar 1, 2020
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
COLCOVID adults undergoing hip fracture surgery	Procedure: Hip fracture surgery; Hip fracture surgery

Outcome Measures

Primary Outcome Measures

1. Hospital Mortality [Day 0 to Day 30]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de NIMES	Nimes		France	30029

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Principal Investigator: Philippe Cuvillon, CHU NIMES

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT04944329
• Other Study ID Numbers: LOCAL/2021/PC-02
• First Posted: Jun 29, 2021
• Last Update Posted: Jul 1, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Fractures, Bone; Hip Fractures

Study Results

No Results Posted as of Jul 1, 2021