Femoral frACturEs and COVID-19.

• Conditions: Covid19; Femur Fracture; Fragility Fracture
• Interventions: Other: COVID-19

• Registration Number: NCT04657510
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief Summary

Retrospective cohort study comparing the early prognosis after surgically-treated proximal femur fragility fractures in patients affected and not affected by COVID-19.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-14
• Study First Submitted: 2020-11-14
• Status Verified: 2020-12
• Primary Completion: 2020-12-01
• Study First Submitted QC: 2020-12-06
• Last Update Submitted: 2020-12-06
• Study First Posted: 2020-12-08
• Last Update Posted: 2020-12-08
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Age ≥45 years
• Admitted to IRCCS Orthopaedic Institute Galeazzi for proximal femur fractures from march 2020 to april 2020.
• Tested for COVID-19 through naso-pharyngeal swab analized with RT-PCR

Exclusion Criteria

• Age <45 years
• Not tested for SARS-CoV-2
• Other fractures (including bilateral proximal femur fractures)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Proximal femur fracture NO COVID	COVID-19	Surgical treatment of femur fracture
Proximal femur fracture AND COVID-19	COVID-19	Surgical treatment of femur fracture

Primary Outcome Measures

Name	Time	Method
Survival at discharge day (comparison between the two groups)	on discharge day, on average after 1 week	Survival at discharge day (comparison between the two groups)

Secondary Outcome Measures

Name	Time	Method
Survival at 30 days after discharge (comparison between the two groups)	30 days after discharge	Survival at 30 days after discharge (comparison between the two groups)
Length of stay (comparison between the two groups)	on discharge day, on average 1 week	Length of stay (comparison between the two groups)
Routine lab exams values (comparison between the two groups)	At admission, 1st postoperative day, 5th postoperative day, on discharge day	Routine lab exams values (comparison between the two groups)
Readmission rate (comparison between the two groups)	up to 30 days after discharge	Readmission rate (comparison between the two groups)
Complications rate (comparison between the two groups)	up to 30 days after discharge	Complications rate (comparison between the two groups)

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Galeazzi; 🇮🇹 Milano, Italy