Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-11
SponsorUMC Utrecht

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MRI

    Diagnostic test

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

  • Scolioscan

    Diagnostic test

    3D ultrasound of the spine

  • Skeletal maturity assessment

    Diagnostic test

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Cohort 13 interventions
Group B: Cohort 23 interventions

Trial outcomes

Primary outcomes

1

Spinal MR Imaging of the thoracic and lumbar spine

MRI images

Time frame
Girls: Baseline
2

Spinal MR Imaging of the thoracic and lumbar spine

MRI images

Time frame
Girls: 11year
3

Spinal MR Imaging of the thoracic and lumbar spine

MRI images

Time frame
Girls: 12year
4

Spinal MR Imaging of the thoracic and lumbar spine

MRI images

Time frame
Girls: 13year

Secondary outcomes

1

A-P ratio vertebrae and disc

Ratio anterior and posterior height

Time frame
Girls: Baseline
2

A-P ratio vertebrae and disc

Ratio anterior and posterior height

Time frame
Girls: 11year
3

A-P ratio vertebrae and disc

Ratio anterior and posterior height

Time frame
Girls: 12year
4

A-P ratio vertebrae and disc

Ratio anterior and posterior height

Time frame
Girls: 13year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UMC Utrecht

Lead sponsor

Eindhoven University of Technology

Collaborator