Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head

Not Applicable

Completed

• Conditions: Osteonecrosis
• Interventions: Diagnostic Test: Magnetic Resonance

• Registration Number: NCT05684588
• Lead Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

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.

Study Timeline

• Study First Submitted: 2021-11-11
• Study Start: 2021-11-15
• Study First Submitted QC: 2023-01-12
• Study First Posted: 2023-01-13
• Primary Completion: 2023-10-10
• Study Completion: 2023-10-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Instrumental diagnostic evaluation	Magnetic Resonance	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

Primary Outcome Measures

Name	Time	Method
Number of patients with femoral osteonecrosis	1 year after previous hospitalization	Number of patients showing osteonecrotic lesions

Secondary Outcome Measures

Name	Time	Method
Definition of the stage of ONFH cases	1 year after previous hospitalization	Stage of ONFH is defined according to ARCO classification criteria
Description of therapies employed during hospitalization	hospitalization time 89 days	Description of therapies including oxygen based therapy, oral anticoagulants (TAO), steroid drugs and other
To describe and define the stage of all ON cases	1 year after previous hospitalization	Stage of other ON types as assessed by ARCO classification criteria
Description of patients clinical features	hospitalization time 89 days	Diseases and relevant clinical characteristic at the time of previous hospitalization for COVID-19
Description of COVID-19	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)
Number of all ON types that will be detected	1 year after previous hospitalization	ON detected in other anatomical sites will be described including proximal humerus and knee

Trial Locations

Locations (1)

ASST-Papa Giovanni XXIII; 🇮🇹 Bergamo, Lombardia, Italy