Explorative Study on Occult Avascular Osteonecrosis in a Pediatric Patients Cohort With Sickle Cell Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Calculate the prevalence of unknown osteonecrosis
Study Overview
Brief Summary
Avascular necrosis (AVN) is a serious complication of sickle cell disease, especially in pediatric patients where the prevalence is between 3% and 8% and are more frequent in patients with multiple vaso-occlusive crisis (VOC). The prevalence of AVN is usually made by a study of the hip through radiography, whereas other possible sites of ischemic infarcts are evaluated only in case of specific symptoms. In addition, bone infarcts may be the trigger for additional VOC.
In this study, we want to investigate the presence of possible bone lesions even in asymptomatic or paucisymptomatic children.
This is a prospective interventional and monocentric study whose objective is to describe the prevalence of osteonecrosis in children with sickle cell disease in Italy
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 7 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female or male patients diagnosed with sickle cell anemia (HbSS, HbS/β0, HbS/β+, HbSC) with or without known avascular lesions
- •Age ≥ 7 and < 18 years at the moment of signed consent
- •Written informed consent/assent, according to local guidelines, signed by patient and/or guidelines, signed by the patient and/or at least one parent or legal guardian
Exclusion Criteria
- •- Any contraindication to perform Nuclear Magnetic Resonance Magnetic Resonance Imaging (MRI)
- •Inability to obtain informed consent/assent
Outcomes
Primary Outcomes
Calculate the prevalence of unknown osteonecrosis
Time Frame: Day 1
Avascular necrosis of the bones are diagnosed by systematic MRI at sites: total spine, femurs, shoulders, humeri and total hip. These data will be collected in the patient's medical record in patients with sickle cell anemia regardless of the number and intensity of vaso-occlusive crisis
Secondary Outcomes
No secondary outcomes reported
Investigators
Vincenzo Voi
MD
San Luigi Gonzaga Hospital