Femoral frACturEs and COVID-19. (FACE COVID-19)

December 6, 2020 updated by: Istituto Ortopedico Galeazzi

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milano, Italy
        • Recruiting
        • IRCCS Istituto Ortopedico Galeazzi
        • Contact:
        • Principal Investigator:
          • Giuseppe M Peretti, MD
        • Sub-Investigator:
          • Ilaria Morelli, MD
        • Sub-Investigator:
          • Riccardo Giorgino, MD
        • Sub-Investigator:
          • Francesco Luceri, MD
        • Sub-Investigator:
          • Francesca Villa, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with >45 years of age admitted to our center from march 2020 to april 2020 for proximal femur fracture and tested for SARS-CoV-2.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Proximal femur fracture AND COVID-19
Surgical treatment of femur fracture
Other: COVID-19
Patients affected versus not affected by COVID-19, with the same starting condition (proximal femur fracture)
Proximal femur fracture NO COVID
Surgical treatment of femur fracture
Other: COVID-19
Patients affected versus not affected by COVID-19, with the same starting condition (proximal femur fracture)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival at discharge day (comparison between the two groups)
Time Frame: on discharge day, on average after 1 week
Survival at discharge day (comparison between the two groups)
on discharge day, on average after 1 week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Investigators

  • Principal Investigator: Giuseppe M Peretti, MD, IRCCS Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 14, 2020

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

November 14, 2020

First Submitted That Met QC Criteria

December 6, 2020

First Posted (ACTUAL)

December 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 6, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FACE COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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