Brief Title
Avascular Bone Necrosis in Sickle Cell Disease: a Pediatric Study.
Official Title
Explorative Study on Occult Avascular Osteonecrosis in a Pediatric Patients Cohort With Sickle Cell Disease
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 Type
Observational [Patient Registry]
Primary Outcome
Calculate the prevalence of unknown osteonecrosis
Condition
Sickle Cell Disease
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
32
Start Date
March 18, 2021
Completion Date
October 27, 2021
Primary Completion Date
October 27, 2021
Eligibility Criteria
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
Gender
All
Ages
7 Years - 17 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT05203991
Organization ID
Osteonecrosis SCD
Responsible Party
Principal Investigator
Study Sponsor
San Luigi Gonzaga Hospital
Study Sponsor
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Verification Date
January 2022