OsteonecrosisCovid-ONNCT05684588
Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head
A study testing Magnetic Resonance in people with Osteonecrosis, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 1 site in Italy.
Trial summary
During the most recent pandemy COVID-19, various advises concerning complications following high corticosteroid doses administration were pubblished in 2020. However, evidence is lacking about the incidence of Non-traumatic osteonecrosis of the femoral head (ONFH) in patients experiencing COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 59 years, men only
- Conditions the study is for
- Osteonecrosis
- What is being tested?
- Magnetic Resonance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2021to 10 Oct 2023
- Phase
- Interventional
- 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 18 to 59 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male
- Age > 18 and < 60 years old
- Hospitalization between 23-Feb-2020 and 21-May-2020 because of COVID-19 diagnosis
- Hospitalization duration > 25 days
- Treatment with steroid drugs during hospitalization (total cumulative dose > 2 g)
- Signature of written informed consent
Who cannot join
- Presence of any implantable medical device defined as 'unsafe' for RM (eg. Cardiac pacemaker; vascular stent and gastrointestinal clips evaluated as 'unsafe')
- Previous experience with episodes and symptoms associated with claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
During the most recent pandemy COVID-19, various advises concerning complications following high corticosteroid doses administration were pubblished in 2020.
However, evidence is lacking about the incidence of Non-traumatic osteonecrosis of the femoral head (ONFH) in patients experiencing COVID-19. The aim of the present proposal is to obtain a quantitative estimation of ONFH cases among patients previoulsy hospitalized and treated for COVID-19 at ASST-Papa Giovanni XXIII.
Read the detailed description
Non-traumatic osteonecrosis of the femoral head (ONFH) is usually asimptomatic, but in advanced stages involves disabilities, leading to the lost of the joint functions.
The classification of the osteonecrosis type is based on clinical and radiographical criteria. Among these, the magnetic resonance (RM) plays a crucial role for detecting lesions in the early asymptomatic phase.
An high incidence of ONFH has been described during the SARS-1 pandemy: it was observed that 40% of males younger than 60, under treatment with corticosteroids, experienced it.
Based on these evidences and avises concerning complications caused by intensive corticosteroid therapy during 2020, the investigators have hypothesized that the ONFH could be underestimated in patients affected by COVID-19 and that it would be diagnosed only in its advanced disabling phase. Therefore, the main aim of this investigation is to obtain an early estimation of cases experiencing ONFH through RM as long-term sequela of COVID-19, including the assessment of articular sites involved. This will be evaluated in patients hospitalized and treated for COVID-19 at ASST-Papa Giovanni XXIII between February 23, 2020 and May 21, 2020.
After enrollment one visit and an instrumental assessment of hip status, including an RM and a radiography, will be scheduled in order to detect lesions at least at 1 year from previous hospitalization.
- Conditions
- Osteonecrosis
- Being tested
- Magnetic Resonance
- Keywords
- Femoral osteonecrosis, Corticosteroids, COVID-19
- Medical subject headings
- Osteonecrosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic ResonanceDiagnostic test
After enrollment a Magnetic Resonance without medium contrast, at 1 year from previous hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Instrumental diagnostic evaluation | Other | After enrollment all patients will undergo an instrumental evaluation including a radiography (according to clinical practice) and a magnetic resonance (experimental procedure outside clinical practice), at 1 year from previous hospitalization Receives: Diagnostic Test: Magnetic Resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with femoral osteonecrosis
Number of patients showing osteonecrotic lesions
Measured: 1 year after previous hospitalization
Secondary outcomes (6)
Description of patients clinical features
Diseases and relevant clinical characteristic at the time of previous hospitalization for COVID-19
Measured: hospitalization time 89 days
Description of COVID-19
COVID-19 outcome in term of worsening (Continuous Positive Airway Pressure - CPAP use; invasive ventilation methods) and improvement status (discharge from Intensive Care Unit -ICU; discharge from hospital)
Measured: hospitalization time 89 days
Description of therapies employed during hospitalization
Description of therapies including oxygen based therapy, oral anticoagulants (TAO), steroid drugs and other
Measured: hospitalization time 89 days
Definition of the stage of ONFH cases
Stage of ONFH is defined according to ARCO classification criteria
Measured: 1 year after previous hospitalization
Number of all ON types that will be detected
ON detected in other anatomical sites will be described including proximal humerus and knee
Measured: 1 year after previous hospitalization
To describe and define the stage of all ON cases
Stage of other ON types as assessed by ARCO classification criteria
Measured: 1 year after previous hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start15 Nov 2021
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteonecrosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an experimental (non-pharmacological) diagnostic, pilot and monocentric study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudio Ca Castelli, Prof, Study chair, FROM-Fondazione per la Ricerca Ospedale di Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684588
- Sponsor's protocol ID
- FROM- O- Covid-ON - 2021
- Acronym
- Covid-ON
- Status last verified
- Feb 2024
- First submitted
- 11 Nov 2021
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head
- ClinicalTrials.gov ID
- NCT05684588
- Acronym / sponsor ID
- Covid-ON / FROM- O- Covid-ON - 2021
- Conditions
- Osteonecrosis
- Keywords
- Femoral osteonecrosis, Corticosteroids, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETSUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 13 Jan 2023 (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.
During the most recent pandemy COVID-19, various advises concerning complications following high corticosteroid doses administration were pubblished in 2020.
However, evidence is lacking about the incidence of Non-traumatic osteonecrosis of the femoral head (ONFH) in patients experiencing COVID-19. The aim of the present proposal is to obtain a quantitative estimation of ONFH cases among patients previoulsy hospitalized and treated for COVID-19 at ASST-Papa Giovanni XXIII.
Detailed description
Non-traumatic osteonecrosis of the femoral head (ONFH) is usually asimptomatic, but in advanced stages involves disabilities, leading to the lost of the joint functions.
The classification of the osteonecrosis type is based on clinical and radiographical criteria. Among these, the magnetic resonance (RM) plays a crucial role for detecting lesions in the early asymptomatic phase.
An high incidence of ONFH has been described during the SARS-1 pandemy: it was observed that 40% of males younger than 60, under treatment with corticosteroids, experienced it.
Based on these evidences and avises concerning complications caused by intensive corticosteroid therapy during 2020, the investigators have hypothesized that the ONFH could be underestimated in patients affected by COVID-19 and that it would be diagnosed only in its advanced disabling phase. Therefore, the main aim of this investigation is to obtain an early estimation of cases experiencing ONFH through RM as long-term sequela of COVID-19, including the assessment of articular sites involved. This will be evaluated in patients hospitalized and treated for COVID-19 at ASST-Papa Giovanni XXIII between February 23, 2020 and May 21, 2020.
After enrollment one visit and an instrumental assessment of hip status, including an RM and a radiography, will be scheduled in order to detect lesions at least at 1 year from previous hospitalization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an experimental (non-pharmacological) diagnostic, pilot and monocentric study
| Arm | Type | Receives |
|---|---|---|
| Instrumental diagnostic evaluation | Other | Diagnostic Test: Magnetic ResonanceAfter enrollment all patients will undergo an instrumental evaluation including a radiography (according to clinical practice) and a magnetic resonance (experimental procedure outside clinical practice), at 1 year from previous hospitalization |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- Age > 18 and < 60 years old
- Hospitalization between 23-Feb-2020 and 21-May-2020 because of COVID-19 diagnosis
- Hospitalization duration > 25 days
- Treatment with steroid drugs during hospitalization (total cumulative dose > 2 g)
Key exclusion criteria (2 listed)
- Presence of any implantable medical device defined as 'unsafe' for RM (eg. Cardiac pacemaker; vascular stent and gastrointestinal clips evaluated as 'unsafe')
- Previous experience with episodes and symptoms associated with claustrophobia.
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 |
|---|---|---|
| Magnetic ResonanceAfter enrollment a Magnetic Resonance without medium contrast, at 1 year from previous hospitalization | Diagnostic test | Instrumental diagnostic evaluation |
Primary outcome
Number of patients with femoral osteonecrosis
Time frame: 1 year after previous hospitalization
Number of patients showing osteonecrotic lesions
6 secondary outcomes
Description of patients clinical features
Time frame: hospitalization time 89 days
Description of COVID-19
Time frame: hospitalization time 89 days
Description of therapies employed during hospitalization
Time frame: hospitalization time 89 days
Definition of the stage of ONFH cases
Time frame: 1 year after previous hospitalization
Number of all ON types that will be detected
Time frame: 1 year after previous hospitalization
To describe and define the stage of all ON cases
Time frame: 1 year after previous hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Claudio Ca Castelli, Prof study chair
FROM-Fondazione per la Ricerca Ospedale di Bergamo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance in people with Osteonecrosis, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 23 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with femoral osteonecrosis (time frame: 1 year after previous hospitalization). 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 23 Feb 2024.