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

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.

Study Overview

• Status: Completed
• Conditions: Osteonecrosis
• Intervention / Treatment: Diagnostic test: Magnetic Resonance

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Bergamo, Lombardia, Italy, 24127
      • ASST-Papa Giovanni XXIII

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Instrumental diagnostic evaluation; 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; After enrollment a Magnetic Resonance without medium contrast, at 1 year from previous hospitalization

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione per la Ricerca Ospedale Maggiore
• Investigators: Study Chair: Claudio Ca Castelli, Prof, FROM-Fondazione per la Ricerca Ospedale di Bergamo

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): October 10, 2023

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; Corticosteroids; Femoral osteonecrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Musculoskeletal Diseases; Bone Diseases; COVID-19; Osteonecrosis
• Other Study ID Numbers: FROM- O- Covid-ON - 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No