Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head

Osteonecrosis Clinical Trial

— Covid-ON  

Official title:

Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05684588
• Other study ID #: FROM- O- Covid-ON - 2021
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: October 10, 2023

Study information

• Verified date: February 2024
• Source: Fondazione per la Ricerca Ospedale Maggiore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 10, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Osteonecrosis

Intervention

Diagnostic Test:
• Magnetic Resonance
After enrollment a Magnetic Resonance without medium contrast, at 1 year from previous hospitalization

Locations

Country	Name	City	State
Italy	ASST-Papa Giovanni XXIII	Bergamo	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione per la Ricerca Ospedale Maggiore

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with femoral osteonecrosis	Number of patients showing osteonecrotic lesions	1 year after previous hospitalization
Secondary	Description of patients clinical features	Diseases and relevant clinical characteristic at the time of previous hospitalization for COVID-19	hospitalization time 89 days
Secondary	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
Secondary	Description of therapies employed during hospitalization	Description of therapies including oxygen based therapy, oral anticoagulants (TAO), steroid drugs and other	hospitalization time 89 days
Secondary	Definition of the stage of ONFH cases	Stage of ONFH is defined according to ARCO classification criteria	1 year after previous hospitalization
Secondary	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
Secondary	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