Actively Recruiting
Led by UMC Utrecht · Updated on 2023-06-29
120
Participants Needed
1
Research Sites
N/A
Total Duration
U
UMC Utrecht
Lead Sponsor
E
Eindhoven University of Technology
Collaborating Sponsor
Researchers are studying adolescent idiopathic scoliosis (AIS), a condition where the spine curves during the adolescent growth spurt, but its exact cause remains unclear. The study focuses on girls and boys at higher risk for scoliosis development, including those with family history and those with 22q11.2 deletion syndrome (22q11.2DS). The goal is to understand differences in spine growth and changes before and during AIS onset using new non-radiation imaging methods. This observational study follows two groups: one of adolescent girls aged 8-10 years with family members diagnosed with AIS, and another of girls and boys aged 8-11 years diagnosed with 22q11.2DS. Participants will undergo spinal MRI and 3D ultrasound scans at multiple time points from ages 8 or 9 to 15 or 16, depending on gender. A hand radiograph for skeletal maturity assessment will be done once. The study aims to track anatomical spine changes over time without any intervention. Participants will have spinal MR imaging of the thoracic and lumbar regions at five scheduled ages to evaluate changes in spinal anatomy, including segmental rotation and disc morphology. Other assessments include spinal alignment, vertebrae and disc volumes, and nucleus pulposus shift. These imaging tests are radiation-free and repeated over several years to create a detailed longitudinal dataset. Parents will provide consent, and the study will monitor growth and scoliosis development until participants reach mid-adolescence.
CONDITIONS
Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From age 8 to 15 years for girls, and from age 9 to 16 years for boys
Participants undergo spinal MRI and 3D ultrasound imaging at multiple time points to evaluate spinal anatomy and changes during growth. A hand radiograph is taken once to assess skeletal maturity.
5 imaging visits over several years
Duration - Up to 7 years depending on participant's age at enrollment
Participants are monitored longitudinally to observe spinal changes and scoliosis development through repeated imaging and assessments.
Follow-up imaging visits aligned with diagnostic evaluation time points
Total: 1 location
1
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
T
Tom Schlosser
H
Hilde Stempels
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Peter P G Lafranca, Hilde W Stempels, Steven de Reuver...
https://pubmed.ncbi.nlm.nih.gov/40578865