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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance | Diagnostic Test | After enrollment a Magnetic Resonance without medium contrast, at 1 year from previous hospitalization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with femoral osteonecrosis | Number of patients showing osteonecrotic lesions | 1 year after previous hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Description of patients clinical features | Diseases and relevant clinical characteristic at the time of previous hospitalization for COVID-19 | hospitalization time 89 days |
| Description of COVID-19 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Ca Castelli, Prof | FROM-Fondazione per la Ricerca Ospedale di Bergamo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST-Papa Giovanni XXIII | Bergamo | Lombardy | 24127 | Italy |
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| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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This is an experimental (non-pharmacological) diagnostic, pilot and monocentric study
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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)
| hospitalization time 89 days |
| Description of therapies employed during hospitalization | Description of therapies including oxygen based therapy, oral anticoagulants (TAO), steroid drugs and other | hospitalization time 89 days |
| Definition of the stage of ONFH cases | Stage of ONFH is defined according to ARCO classification criteria | 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 | 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 | 1 year after previous hospitalization |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |