Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development
- Conditions
- Adolescent Idiopathic Scoliosis22q11.2 Deletion Syndrome
- Interventions
- Diagnostic Test: MRIDiagnostic Test: ScolioscanDiagnostic Test: Skeletal maturity assessment
- Registration Number
- NCT05924347
- Lead Sponsor
- UMC Utrecht
- 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.
- Detailed Description
Objective: The primary objectives is: To longitudinally evaluate the substantial differences in anatomical changes in the spine during adolescent growth in girls, at increased risk for scoliosis development, and in adolescent 22q11.2DS patients, that do and do not develop AIS.
The secondary objectives are:
* To develop spine specific (IVD/endplates) maturity assessment grading.
* To implement radiation-free imaging methods for spinal monitoring in adolescent patients at risk for scoliosis development.
* To create a longitudinal dataset for patient specific spinal biomechanical assessment.
Study design: Prospective observational cohort study
Study population: 60 adolescent girls (8-10 years old) at increased risk for idiopathic scoliosis development (an older sibling or parent diagnosed with idiopathic scoliosis) (Cohort-1) and 60 adolescent girls and boys with 22q11.2DS with increased risk for idiopathic-like scoliosis development (Cohort-2).
Intervention: none
Main study parameters/endpoints: Spinal MR imaging of the thoracic and lumbar spine will be performed at 5 time points between 8 or 9 and 15 or 16 for girls and boys respectively to evaluate possible changes in the 3D anatomy of the spine. The main study parameter will be the longitudinal changes in segmental axial rotation on boneMRI of the thoracolumbar spine in subjects that do and do not develop AIS.
Secondary endpoints: Changes in bone and intervertebral disc morphology, lateral shift of the nucleus pulposus. These will be correlated to assessments of growth, skeletal maturity and spinal alignment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 MRI 60 adolescent girls (8-10 years old) at increased risk for idiopathic scoliosis development (an older sibling or parent diagnosed with idiopathic scoliosis) Cohort 2 MRI 60 adolescent girls or boys with the 22q11.2DS with increased risk for idiopathic-like scoliosis development. Cohort 2 Scolioscan 60 adolescent girls or boys with the 22q11.2DS with increased risk for idiopathic-like scoliosis development. Cohort 1 Scolioscan 60 adolescent girls (8-10 years old) at increased risk for idiopathic scoliosis development (an older sibling or parent diagnosed with idiopathic scoliosis) Cohort 1 Skeletal maturity assessment 60 adolescent girls (8-10 years old) at increased risk for idiopathic scoliosis development (an older sibling or parent diagnosed with idiopathic scoliosis) Cohort 2 Skeletal maturity assessment 60 adolescent girls or boys with the 22q11.2DS with increased risk for idiopathic-like scoliosis development.
- Primary Outcome Measures
Name Time Method Spinal MR Imaging of the thoracic and lumbar spine Boys: 16year MRI images
- Secondary Outcome Measures
Name Time Method Torsion Boys: 16year Difference in axial rotation between 2 subsequent endplates
Volumes vertebrae Boys: 16year Volumes vertebrae
Shift nucleus pulposis Boys: 16year Position of nucleus pulposus in discus
Changes in spinal alignment during growth Girls: Baseline-15years, Boys: Baseline-15years Scan for changes over growth
Left-right ratio Boys: 16year Ratio left and right height
Volumes disc Boys: 16year Volumes disc
A-P ratio vertebrae and disc Boys: 14year Ratio anterior and posterior height
A-P ratio vertebrae Boys: 16year Ratio anterior and posterior height
Spine specific maturity assessment grading Girls: Baseline-15years, Boys: Baseline-15years See if it is possible to create a spine specific maturity assessment
Trial Locations
- Locations (1)
UMC Utrecht
🇳🇱Utrecht, Netherlands