Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development

Recruiting now

Conditions studied: Adolescent Idiopathic Scoliosis, 22q11.2 Deletion Syndrome

In brief

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.

Key facts

Study ID

NCT05924347

Run by

UMC Utrecht

People needed

120

Starts

2023-06-16

Expected to finish

2032-05-01

Last updated by the study team

2023-06-29

Who can join

Age: 8 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• UMC Utrecht — Utrecht, Netherlands (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.