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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05203991

Acronym

OsteoSCD

Enrollment

Registered

2022-01-24

Start date

2021-03-18

Completion date

2021-10-27

Last updated

2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Keywords

Avascular necrosis

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Calculate the prevalence of unknown osteonecrosis	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

Countries

Italy

Outcome results