Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2023-10-10

Brief Summary

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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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Detailed Description

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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.

Conditions

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Osteonecrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is an experimental (non-pharmacological) diagnostic, pilot and monocentric study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Magnetic Resonance

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Magnetic Resonance

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No