Evaluating early spinal changes in children at risk for scoliosis
Longitudinal MRI Study to Catch EARLY Scoliotic Changes of the Bone and Intervertebral Disc in Younger Sisters and Daughters of Adolescent Idiopathic Scoliosis Patients and the 22q11.2DS Population.
This study is trying to see how the spines of adolescent girls at risk for scoliosis and kids with a specific genetic condition change over time using MRI scans, to better understand who might develop scoliosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 8 Years to 11 Years |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT05924347 on ClinicalTrials.gov |
What this trial studies
This observational study aims to longitudinally assess anatomical changes in the spines of adolescent girls at increased risk for developing adolescent idiopathic scoliosis (AIS) and boys and girls with 22q11.2 deletion syndrome. The study will involve 60 participants from each cohort, monitored through MRI imaging at five different time points during their growth years. The primary focus is to identify differences in spinal development between those who do and do not develop AIS, while also implementing radiation-free imaging techniques. The study seeks to create a comprehensive dataset for understanding spinal biomechanics and maturity assessment.
Who should consider this trial
Good fit: Ideal candidates include adolescent girls aged 8-10 with a family history of scoliosis and boys and girls aged 9-11 diagnosed with 22q11.2 deletion syndrome.
Not a fit: Patients with existing spinal deformities or other syndromes associated with scoliosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and early detection of scoliosis, potentially allowing for timely interventions.
How similar studies have performed: While there have been studies on established scoliosis, this approach of assessing early spinal changes in at-risk populations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Utrecht
- UMC Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Tom Schlosser
- Email: t.p.c.schlosser@umcutrecht.nl
- Phone: +31 88 75 53602
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.