Avascular Bone Necrosis in Sickle Cell Disease: a Pediatric Study.

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

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Bone Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU San Luigi Gonzaga

Orbassano, Torino, 10043, Italy

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

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Sponsors and collaborators

Lead sponsor

San Luigi Gonzaga Hospital

Other

Registry information

Official study title

Explorative Study on Occult Avascular Osteonecrosis in a Pediatric Patients Cohort With Sickle Cell Disease

Acronym: OsteoSCD

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Jan 24, 2022
Registry last updated: Jan 24, 2022

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.

Published trials that share one or more normalized conditions with this study.

Active, not recruiting