Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head (Covid-ON)

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Status: Completed

Conditions: Osteonecrosis

Treatments: Diagnostic Test: Magnetic Resonance

Study type: Interventional

Funder types: Other

Identifiers

NCT05684588

FROM- O- Covid-ON - 2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: Male

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Instrumental diagnostic evaluation

Other group

Description:

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

Treatment:

Diagnostic Test: Magnetic Resonance