Clinical trial NCT05684588: Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head
Official title: Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteonecrosis
Keywords: Femoral osteonecrosis
Corticosteroids
COVID-19
Lead sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an experimental (non-pharmacological) diagnostic, pilot and monocentric study
Primary purpose: DIAGNOSTIC

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with femoral osteonecrosis
timeFrame: 1 year after previous hospitalization
Secondary outcomes:
measure: Description of patients clinical features
timeFrame: hospitalization time 89 days
measure: Description of COVID-19
timeFrame: hospitalization time 89 days
measure: Description of therapies employed during hospitalization
timeFrame: hospitalization time 89 days
measure: Definition of the stage of ONFH cases
timeFrame: 1 year after previous hospitalization
measure: Number of all ON types that will be detected
timeFrame: 1 year after previous hospitalization
measure: To describe and define the stage of all ON cases
timeFrame: 1 year after previous hospitalization
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: ASST-Papa Giovanni XXIII
state: Lombardia
Study officials:
affiliation: FROM-Fondazione per la Ricerca Ospedale di Bergamo
name: Claudio Ca Castelli, Prof
role: STUDY_CHAIR
References: