Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head
Covid-ON
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2021
CompletedStudy Start
First participant enrolled
November 15, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2023
CompletedFebruary 23, 2024
February 1, 2024
1.9 years
November 11, 2021
February 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with femoral osteonecrosis
Number of patients showing osteonecrotic lesions
1 year after previous hospitalization
Secondary Outcomes (6)
Description of patients clinical features
hospitalization time 89 days
Description of COVID-19
hospitalization time 89 days
Description of therapies employed during hospitalization
hospitalization time 89 days
Definition of the stage of ONFH cases
1 year after previous hospitalization
Number of all ON types that will be detected
1 year after previous hospitalization
- +1 more secondary outcomes
Study Arms (1)
Instrumental diagnostic evaluation
OTHERAfter 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
Interventions
After enrollment a Magnetic Resonance without medium contrast, at 1 year from previous hospitalization
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ASST-Papa Giovanni XXIII
Bergamo, Lombardy, 24127, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Claudio Ca Castelli, Prof
FROM-Fondazione per la Ricerca Ospedale di Bergamo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2021
First Posted
January 13, 2023
Study Start
November 15, 2021
Primary Completion
October 10, 2023
Study Completion
October 10, 2023
Last Updated
February 23, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share