Covid19FACE COVID-19NCT04657510
Femoral frACturEs and COVID-19.
An observational study of Covid19 and Femur Fracture, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Covid19, Femur Fracture, Fragility Fracture
- What is being tested?
- COVID-19
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 14 Nov 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age <45 years
- Not tested for SARS-CoV-2
- Other fractures (including bilateral proximal femur fractures)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Galeazzi
Milan
Giuseppe M Peretti, MD, 0039 3396610282, giuseppe.peretti@unimi.it
Giuseppe M Peretti, MD
About this study
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.
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
- Being tested
- COVID-19
- Keywords
- proximal femur fracture, fragility fracture, Covid-19, SARS-CoV2, FACE-COVID 19, prognosis, cohort study
- Medical subject headings
- COVID-19, Femoral Fractures, Proximal Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19Other
Patients affected versus not affected by COVID-19, with the same starting condition (proximal femur fracture)
| Study group | Role | What they receive |
|---|---|---|
| Proximal femur fracture AND COVID-19 | Surgical treatment of femur fracture Receives: Other: COVID-19 | |
| Proximal femur fracture NO COVID | Surgical treatment of femur fracture Receives: Other: COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at discharge day (comparison between the two groups)
Survival at discharge day (comparison between the two groups)
Measured: on discharge day, on average after 1 week
Secondary outcomes (5)
Length of stay (comparison between the two groups)
Length of stay (comparison between the two groups)
Measured: on discharge day, on average 1 week
Readmission rate (comparison between the two groups)
Readmission rate (comparison between the two groups)
Measured: up to 30 days after discharge
Complications rate (comparison between the two groups)
Complications rate (comparison between the two groups)
Measured: up to 30 days after discharge
Survival at 30 days after discharge (comparison between the two groups)
Survival at 30 days after discharge (comparison between the two groups)
Measured: 30 days after discharge
Routine lab exams values (comparison between the two groups)
Routine lab exams values (comparison between the two groups)
Measured: At admission, 1st postoperative day, 5th postoperative day, on discharge day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start14 Nov 2020
- Primary completion1 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe M Peretti, MD, Principal investigator, IRCCS Istituto Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657510
- Sponsor's protocol ID
- FACE COVID-19
- Acronym
- FACE COVID-19
- Status last verified
- Dec 2020
- First submitted
- 14 Nov 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04657510
- Acronym / sponsor ID
- FACE COVID-19 / FACE COVID-19
- Conditions
- Covid19, Femur Fracture, Fragility Fracture
- Keywords
- proximal femur fracture, fragility fracture, Covid-19, SARS-CoV2, FACE-COVID 19, prognosis, cohort study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 14 Nov 2020 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective cohort study comparing the early prognosis after surgically-treated proximal femur fragility fractures in patients affected and not affected by COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal femur fracture AND COVID-19 | – | Other: COVID-19Surgical treatment of femur fracture |
| Proximal femur fracture NO COVID | – | Other: COVID-19Surgical treatment of femur fracture |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Age <45 years
- Not tested for SARS-CoV-2
- Other fractures (including bilateral proximal femur fractures)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19Patients affected versus not affected by COVID-19, with the same starting condition (proximal femur fracture) | Other | Proximal femur fracture AND COVID-19, Proximal femur fracture NO COVID |
Primary outcome
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)
5 secondary outcomes
Length of stay (comparison between the two groups)
Time frame: on discharge day, on average 1 week
Readmission rate (comparison between the two groups)
Time frame: up to 30 days after discharge
Complications rate (comparison between the two groups)
Time frame: up to 30 days after discharge
Survival at 30 days after discharge (comparison between the two groups)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe M Peretti, MD principal investigator
IRCCS Istituto Ortopedico Galeazzi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Femur Fracture, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe M Peretti, MD (0039 3396610282, giuseppe.peretti@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at discharge day (comparison between the two groups) (time frame: on discharge day, on average after 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.