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RECRUITING
NCT05924347

Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development

Sponsor: UMC Utrecht

View on ClinicalTrials.gov

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.

Official title: Longitudinal MRI Study to Catch EARLY Scoliotic Changes of the Bone and Intervertebral Disc in Younger Sisters and Daughters of Adolescent Idiopathic Scoliosis Patients and the 22q11.2DS Population.

Key Details

Gender

All

Age Range

8 Years - 11 Years

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2023-06-16

Completion Date

2032-05-01

Last Updated

2023-06-29

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

MRI

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

DIAGNOSTIC_TEST

Scolioscan

3D ultrasound of the spine

DIAGNOSTIC_TEST

Skeletal maturity assessment

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

Locations (1)

UMC Utrecht

Utrecht, Netherlands