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

Primary Purpose

Osteonecrosis

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Magnetic Resonance
Sponsored by
Fondazione per la Ricerca Ospedale Maggiore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteonecrosis focused on measuring Femoral osteonecrosis, Corticosteroids, COVID-19

Eligibility Criteria

18 Years - 59 Years (Adult)MaleDoes not accept 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.

Sites / Locations

  • ASST-Papa Giovanni XXIII

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Instrumental diagnostic evaluation

Arm 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

Outcomes

Primary Outcome Measures

Number of patients with femoral osteonecrosis
Number of patients showing osteonecrotic lesions

Secondary Outcome Measures

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

Full Information

First Posted
November 11, 2021
Last Updated
January 12, 2023
Sponsor
Fondazione per la Ricerca Ospedale Maggiore
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1. Study Identification

Unique Protocol Identification Number
NCT05684588
Brief Title
Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head
Acronym
Covid-ON
Official Title
Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione per la Ricerca Ospedale Maggiore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteonecrosis
Keywords
Femoral osteonecrosis, Corticosteroids, COVID-19

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an experimental (non-pharmacological) diagnostic, pilot and monocentric study
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Instrumental diagnostic evaluation
Arm Type
Other
Arm 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
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic Resonance
Intervention Description
After enrollment a Magnetic Resonance without medium contrast, at 1 year from previous hospitalization
Primary Outcome Measure Information:
Title
Number of patients with femoral osteonecrosis
Description
Number of patients showing osteonecrotic lesions
Time Frame
1 year after previous hospitalization
Secondary Outcome Measure Information:
Title
Description of patients clinical features
Description
Diseases and relevant clinical characteristic at the time of previous hospitalization for COVID-19
Time Frame
hospitalization time 89 days
Title
Description of COVID-19
Description
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)
Time Frame
hospitalization time 89 days
Title
Description of therapies employed during hospitalization
Description
Description of therapies including oxygen based therapy, oral anticoagulants (TAO), steroid drugs and other
Time Frame
hospitalization time 89 days
Title
Definition of the stage of ONFH cases
Description
Stage of ONFH is defined according to ARCO classification criteria
Time Frame
1 year after previous hospitalization
Title
Number of all ON types that will be detected
Description
ON detected in other anatomical sites will be described including proximal humerus and knee
Time Frame
1 year after previous hospitalization
Title
To describe and define the stage of all ON cases
Description
Stage of other ON types as assessed by ARCO classification criteria
Time Frame
1 year after previous hospitalization

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Ca Castelli, Prof
Organizational Affiliation
FROM-Fondazione per la Ricerca Ospedale di Bergamo
Official's Role
Study Chair
Facility Information:
Facility Name
ASST-Papa Giovanni XXIII
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head

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