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

Completed

• Conditions: Sickle Cell Disease

• Registration Number: NCT05203991
• Lead Sponsor: San Luigi Gonzaga Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-18
• Primary Completion: 2021-10-27
• Study Completion: 2021-10-27
• Status Verified: 2022-01
• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Last Update Submitted: 2022-01-10
• Study First Posted: 2022-01-24
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AOU San Luigi Gonzaga; 🇮🇹 Orbassano, Torino, Italy