ASST-Papa Giovanni XXIII
Bergamo, Lombardy, 24127, Italy
NCT Number: NCT05684588
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.
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Notify Me18 year–59 year
Male
Interventional
Not applicable
Bergamo, Lombardy, 24127, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After enrollment a Magnetic Resonance without medium contrast, at 1 year from previous hospitalization
Time frame: 1 year after previous hospitalization
Number of patients showing osteonecrotic lesions
Time frame: hospitalization time 89 days
Diseases and relevant clinical characteristic at the time of previous hospitalization for COVID-19
Time frame: hospitalization time 89 days
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)
Time frame: hospitalization time 89 days
Description of therapies including oxygen based therapy, oral anticoagulants (TAO), steroid drugs and other
Time frame: 1 year after previous hospitalization
Stage of ONFH is defined according to ARCO classification criteria
Time frame: 1 year after previous hospitalization
ON detected in other anatomical sites will be described including proximal humerus and knee
Time frame: 1 year after previous hospitalization
Stage of other ON types as assessed by ARCO classification criteria
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Other
Acronym: Covid-ON
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