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Clinical Trials in the Netherlands / NCT05924347
Recruiting Observational

Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development

NCT05924347 · tracked via the Priya Life Science Netherlands tracker
Phase
Observational
Started
2023-06-16
Last updated
2023-06-29

Condition(s) studied

Adolescent Idiopathic Scoliosis22q11.2 Deletion Syndrome

Investigational drug(s) / intervention(s)

MRIScolioscanSkeletal maturity assessment

MRI: Longitudinal MRI examination of the thoracic and lumbar spine (T2, T2w, sCT)

Scolioscan: 3D ultrasound of the spine

Skeletal maturity assessment: At one timepoint, a Hand radiograph is taken for digital skeletal maturity assessment

Study summary

Rationale: Despite several decades of research, the exact etiology of adolescent idiopathic scoliosis (AIS) remains unclear. In AIS, spine curvature begins with and progresses during the adolescent growth spurt. Previous studies are only performed on populations with already established scoliosis and normal spinal growth (of bone and IVD tissue) during adolescence has also not been defined. Growth pattern differences may exist between scoliotic and nonscoliotic subjects. Previous studies support the hypothesis that AIS is a spinal deformity that starts with decompensation in the IVD and is linked to sagittal spinal alignment. However, to understand its cause and pathogenic mechanism, the changes to the adolescent spine must be assessed longitudinally during the growth period coinciding with the period prior to and during the onset of AIS. Ideally this should include a cohort who do and do not develop AIS and their assessment must be minimally harmful, without radiation exposure. Certain populations are at increased risk for scoliosis development (i.e. girls with family members with scoliosis and 22q11.2DS patients). New imaging modalities (boneMRI, 3D spinal ultrasound) allow for non-radiographic monitoring of spinal growth.

Eligibility

Sex
ALL
Min age
8 Years
Max age
11 Years
Healthy volunteers
No
Inclusion Criteria: Cohort 1: * Female, * 8, 9 or 10 years old * An older sibling, twin or parent diagnosed with AIS Cohort 2: * Diagnosed with 22q11.2DS * Girls: 8, 9 or 10 years old. * Boys: 9, 10 or 11 years old. All * No clinical signs of scoliosis at inclusion (physical examination by forward bending test and Bunnell Scoliometer assessment with a cut-off value of 7°. * Written informed consent of parents/legal representatives. Exclusion Criteria: * Contraindications for MR imaging * Early-onset scoliosis or other spinal deformities * Other syndromes or neuromuscular disease associated with scoliosis * Clinical signs of \>1cm leg length discrepancy * Other diseases or injuries, that are related to abnormal spinal growth, posture, activity levels, or scoliosis development.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
UMC Utrecht Utrecht Netherlands Recruiting

More UMC Utrecht trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05924347 on ClinicalTrials.gov ↗ ← All trials in the Netherlands