Femoral frACturEs and COVID-19.

NCT04657510 | Unknown

• 1 other identifier: FACE COVID-19
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Femur Fracture; Fragility Fracture

Keywords

proximal femur fracture; fragility fracture; Covid-19; SARS-CoV2; FACE-COVID 19; prognosis; cohort study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Length of stay (comparison between the two groups)

  on discharge day, on average 1 week

• Readmission rate (comparison between the two groups)

  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)

  30 days after discharge

• Routine lab exams values (comparison between the two groups)

  At admission, 1st postoperative day, 5th postoperative day, on discharge day

Study Arms (2)

Proximal femur fracture AND COVID-19

Surgical treatment of femur fracture

Other: COVID-19

Proximal femur fracture NO COVID

Surgical treatment of femur fracture

Other: COVID-19

Interventions

COVID-19 OTHER

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

Proximal femur fracture AND COVID-19; Proximal femur fracture NO COVID

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19; Femoral Fractures; Proximal Femoral Fractures

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Neck Fractures; Hip Fractures; Hip Injuries

Study Officials

• Giuseppe M Peretti, MD

  IRCCS Istituto Ortopedico Galeazzi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe M Peretti, MD

CONTACT

0039 3396610282; giuseppe.peretti@unimi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2020
• First Posted: December 8, 2020
• Study Start: November 14, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 31, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

IT (1)