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

NCT05203991 | Completed

• 1 other identifier: Osteonecrosis SCD
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Sickle Cell Disease

Keywords

Avascular necrosis

Outcome Measures

Primary Outcomes (1)

• Calculate the prevalence of unknown osteonecrosis

  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

  Day 1

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Sickle cell pediatric patients followed in consultation in Microcitemie Centre within the framework of their sickle cell disease at San Luigi Gonzaga Hospital, Orbassano (Turin), Italy

You may qualify if:

• 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

You may not qualify if:

• \- Any contraindication to perform Nuclear Magnetic Resonance Magnetic Resonance Imaging (MRI)
• Inability to obtain informed consent/assent

Sponsors & Collaborators

• San Luigi Gonzaga Hospital: lead

Study Sites (1)

AOU San Luigi Gonzaga

Orbassano, Torino, 10043, Italy

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Osteonecrosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: March 18, 2021
• Primary Completion: October 27, 2021
• Study Completion: October 27, 2021
• Last Updated: January 24, 2022

Record last verified: 2022-01

Locations

IT (1)