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 in boys and girls of the 22q11.2DS population.

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 in boys and girls of the 22q11.2DS population. - Earlybird

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53775

Enrollment

120

Registered

2023-03-08

Start date

2023-06-05

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

scoliose 3D curve of the spine curvature of the spine

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Cohort 1: - Female, - 8, 9 or 10 years old - An older sibling, twin or parent diagnosed with AIS - 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. Cohort 2: - Diagnosed with 22q11.2DS - Girls: 8, 9 or 10 years old. - Boys: 9, 10 or 11 years old. - 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

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.

Design outcomes

Primary

Measure	Time frame
The main study parameter will be the longitudinal changes in segmental axial rotation on MRI of the thoracolumbar spine in subjects that do and do not develop AIS.	—

Secondary

Measure	Time frame
1. Changes in bone and intervertebral disc morphology (A-P, left-right ratio, torsion, volumes, shift of the nucleus pulposus) during growth. 2. Changes in spinal alignment during growth 3. Spine specific (IVD/endplates) maturity assessment grading. 4. Spine specific maturity assessment grading in relation to: o Skeletal maturity (Greulich and Pyle digital skeletal age) o Biological maturity (age, menarche, as well as potential markers for endochondral ossification identified in the future that can be measured on the samples in the concurrent biobank of this study population (examples are vit D, serum collagen X matrix, Osteopontin) o Generalized joint hypermobility (Beighton/Bulbena score) o Spinal alignment and length in the upright position and supine position o Spinal cord morphology changes (conus level) during growth o Chest wall shape development (shape, size and volume) All above in subjects that do versus those that do not develop scoliosis	—

Measure

Time frame

1. Changes in bone and intervertebral disc morphology (A-P, left-right ratio, torsion, volumes, shift of the nucleus pulposus) during growth. 2. Changes in spinal alignment during growth 3. Spine specific (IVD/endplates) maturity assessment grading. 4. Spine specific maturity assessment grading in relation to: o Skeletal maturity (Greulich and Pyle digital skeletal age) o Biological maturity (age, menarche, as well as potential markers for endochondral ossification identified in the future that can be measured on the samples in the concurrent biobank of this study population (examples are vit D, serum collagen X matrix, Osteopontin) o Generalized joint hypermobility (Beighton/Bulbena score) o Spinal alignment and length in the upright position and supine position o Spinal cord morphology changes (conus level) during growth o Chest wall shape development (shape, size and volume) All above in subjects that do versus those that do not develop scoliosis

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Countries

Netherlands

Outcome results