Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Number of patients with femoral osteonecrosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Magnetic Resonance (Diagnostic Test)
结局指标
主要结局
Number of patients with femoral osteonecrosis
时间窗: 1 year after previous hospitalization
Number of patients showing osteonecrotic lesions
次要结局
- Definition of the stage of ONFH cases(1 year after previous hospitalization)
- Description of therapies employed during hospitalization(hospitalization time 89 days)
- To describe and define the stage of all ON cases(1 year after previous hospitalization)
- Description of patients clinical features(hospitalization time 89 days)
- Description of COVID-19(hospitalization time 89 days)
- Number of all ON types that will be detected(1 year after previous hospitalization)