NCT05924347 Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development
| NCT ID | NCT05924347 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UMC Utrecht |
| Condition | Adolescent Idiopathic Scoliosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-06-16 |
| Primary Completion | 2032-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2023-06-16 with a primary completion date of 2032-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: Cohort 1: * Female, * 8, 9 or 10 years old * An older sibling, twin or parent diagnosed with AIS Cohort 2: * Diagnosed with 22q11.2DS * Girls: 8, 9 or 10 years old. * Boys: 9, 10 or 11 years old. All * No clinical signs of scoliosis at inclusion (physical examination by forward bending test and Bunnell Scoliometer assessment with a cut-off value of 7°. * Written informed consent of parents/legal representatives. Exclusion Criteria: * 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 * Other diseases or injuries, that are related to abnormal spinal growth, posture, activity levels, or scoliosis development.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05924347 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 11 Years, studying Adolescent Idiopathic Scoliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05924347 currently recruiting?
Yes, NCT05924347 is actively recruiting participants. Contact the research team at t.p.c.schlosser@umcutrecht.nl for enrollment information.
Where is the NCT05924347 trial being conducted?
This trial is being conducted at Utrecht, Netherlands.
Who is sponsoring the NCT05924347 clinical trial?
NCT05924347 is sponsored by UMC Utrecht. The trial plans to enroll 120 participants.