Longitudinal Study Using MRI and 3D Ultrasound to Track Early Spine Changes in Children at Risk for Adolescent Idiopathic Scoliosis and 22q11.2 Deletion Syndrome
Led by UMC Utrecht · Updated on 2023-06-29
120
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
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
Brief Title
Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development
Research Team
T
Tom Schlosser
H
Hilde Stempels
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Female aged 8, 9, or 10 years with an older sibling, twin, or parent diagnosed with adolescent idiopathic scoliosis (Cohort 1)
Diagnosed with 22q11.2 deletion syndrome
Girls aged 8, 9, or 10 years; boys aged 9, 10, or 11 years (Cohort 2)
No clinical signs of scoliosis at inclusion as determined by physical examination and Bunnell Scoliometer assessment with a cut-off value of 7°
Written informed consent from parents or legal representatives
You will not qualify if you...
Contraindications for MR imaging
Early-onset scoliosis or other spinal deformities
Other syndromes or neuromuscular diseases associated with scoliosis
Clinical signs of leg length discrepancy over 1 cm
Other diseases or injuries related to abnormal spinal growth, posture, activity levels, or scoliosis development
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
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
Long-term Monitoring
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
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
EARLYBIRD: catching the earliest changes of the bone and intervertebral discs in children at increased risk for scoliosis development with MRI - study protocol of a prospective observational cohort study.
Peter P G Lafranca, Hilde W Stempels, Steven de Reuver...