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Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development

NCT05924347 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2023-06-29

No results posted yet for this 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.

Conditions

  • Adolescent Idiopathic Scoliosis
  • 22q11.2 Deletion Syndrome

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

Sponsors & Collaborators

  • Eindhoven University of Technology

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Eligibility

Min Age
8 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2032-05-31
Completion
2032-05-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05924347 on ClinicalTrials.gov