Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head

Conditions
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Osteonecrosis

Intervention / Treatment
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* Diagnostic Test: Magnetic Resonance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This is an experimental (non-pharmacological) diagnostic, pilot and monocentric study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Instrumental diagnostic evaluation<br>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 | Diagnostic Test: Magnetic Resonance<br>* After enrollment a Magnetic Resonance without medium contrast, at 1 year from previous hospitalization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with femoral osteonecrosis | Number of patients showing osteonecrotic lesions | 1 year after previous hospitalization | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoral osteonecrosis, Corticosteroids, COVID-19