About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Female,
8, 9 or 10 years old
An older sibling, twin or parent diagnosed with AIS
Diagnosed with 22q11.2DS
Disqualifiers
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
Trial population
Cohort 1: 60 adolescent girls (8-10 years old) at increased risk for idiopathic scoliosis development (an older sibling or parent diagnosed with idiopathic scoliosis) Cohort 2: 60 adolescent girls or boys with the 22q11.2DS with increased risk for idiopathic-like scoliosis development.
Trial design
Cohort
Prospective
Treatments tested in this trial
MRI
Diagnostic testLongitudinal MRI examination of the thoracic and lumbar spine (T2, T2w, sCT)
Scolioscan
Diagnostic test3D ultrasound of the spine
Skeletal maturity assessment
Diagnostic testAt one timepoint, a Hand radiograph is taken for digital skeletal maturity assessment
Treatment groups
Trial outcomes
Primary outcomes
Spinal MR Imaging of the thoracic and lumbar spine
MRI images
Spinal MR Imaging of the thoracic and lumbar spine
MRI images
Spinal MR Imaging of the thoracic and lumbar spine
MRI images
Spinal MR Imaging of the thoracic and lumbar spine
MRI images
Secondary outcomes
A-P ratio vertebrae and disc
Ratio anterior and posterior height
A-P ratio vertebrae and disc
Ratio anterior and posterior height
A-P ratio vertebrae and disc
Ratio anterior and posterior height
A-P ratio vertebrae and disc
Ratio anterior and posterior height
Sponsors and contacts
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UMC Utrecht
Lead sponsor
Eindhoven University of Technology
Collaborator