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NCT04657510 Clinical Trial

Femoral frACturEs and COVID-19.

Covid19 Clinical Trial

— FACE COVID-19  

Official title:
Femoral frACturEs and COVID-19. Retrospective Comparative Cohort Study on the Early Prognosis of Patients Affected by Proximal Femur Fractures and COVID-19.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04657510
Other study ID # FACE COVID-19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 14, 2020
Est. completion date December 31, 2020

Study information
Verified date December 2020
Source Istituto Ortopedico Galeazzi
Contact Giuseppe M Peretti, MD
Phone 0039 3396610282
Email giuseppe.peretti@unimi.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 140
Est. completion date December 31, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• COVID-19
Patients affected versus not affected by COVID-19, with the same starting condition (proximal femur fracture)

Locations
Country Name City State
Italy IRCCS Istituto Ortopedico Galeazzi Milano

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival at discharge day (comparison between the two groups) Survival at discharge day (comparison between the two groups) on discharge day, on average after 1 week
Secondary Length of stay (comparison between the two groups) Length of stay (comparison between the two groups) on discharge day, on average 1 week
Secondary Readmission rate (comparison between the two groups) Readmission rate (comparison between the two groups) up to 30 days after discharge
Secondary Complications rate (comparison between the two groups) Complications rate (comparison between the two groups) up to 30 days after discharge
Secondary Survival at 30 days after discharge (comparison between the two groups) Survival at 30 days after discharge (comparison between the two groups) 30 days after discharge
Secondary Routine lab exams values (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
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