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Completed

NCT Number: NCT05684588

Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic Resonance

Diagnostic Test

After enrollment a Magnetic Resonance without medium contrast, at 1 year from previous hospitalization

Primary outcomes

  1. Number of patients with femoral osteonecrosis

    Time frame: 1 year after previous hospitalization

    Number of patients showing osteonecrotic lesions

Secondary outcomes

  1. Description of patients clinical features

    Time frame: hospitalization time 89 days

    Diseases and relevant clinical characteristic at the time of previous hospitalization for COVID-19

  2. Description of COVID-19

    Time frame: 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)

  3. Description of therapies employed during hospitalization

    Time frame: hospitalization time 89 days

    Description of therapies including oxygen based therapy, oral anticoagulants (TAO), steroid drugs and other

  4. Definition of the stage of ONFH cases

    Time frame: 1 year after previous hospitalization

    Stage of ONFH is defined according to ARCO classification criteria

  5. Number of all ON types that will be detected

    Time frame: 1 year after previous hospitalization

    ON detected in other anatomical sites will be described including proximal humerus and knee

  6. To describe and define the stage of all ON cases

    Time frame: 1 year after previous hospitalization

    Stage of other ON types as assessed by ARCO classification criteria

Sponsors and collaborators

Lead sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Other

Registry information

Acronym: Covid-ON

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2023
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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