Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development (EARLYBIRD)
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ClinicalTrials.gov Identifier: NCT05924347 |
Recruitment Status :
Recruiting
First Posted : June 29, 2023
Last Update Posted : June 29, 2023
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Condition or disease | Intervention/treatment |
---|---|
Adolescent Idiopathic Scoliosis 22q11.2 Deletion Syndrome | Diagnostic Test: MRI Diagnostic Test: Scolioscan Diagnostic Test: Skeletal maturity assessment |
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.
Study Type : | Observational |
Estimated Enrollment : | 120 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 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. |
Actual Study Start Date : | June 16, 2023 |
Estimated Primary Completion Date : | May 2032 |
Estimated Study Completion Date : | May 1, 2032 |
Group/Cohort | Intervention/treatment |
---|---|
Cohort 1
60 adolescent girls (8-10 years old) at increased risk for idiopathic scoliosis development (an older sibling or parent diagnosed with idiopathic scoliosis)
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Diagnostic Test: MRI
Longitudinal MRI examination of the thoracic and lumbar spine (T2, T2w, sCT) Diagnostic Test: Scolioscan 3D ultrasound of the spine Diagnostic Test: Skeletal maturity assessment At one timepoint, a Hand radiograph is taken for digital skeletal maturity assessment |
Cohort 2
60 adolescent girls or boys with the 22q11.2DS with increased risk for idiopathic-like scoliosis development.
|
Diagnostic Test: MRI
Longitudinal MRI examination of the thoracic and lumbar spine (T2, T2w, sCT) Diagnostic Test: Scolioscan 3D ultrasound of the spine Diagnostic Test: Skeletal maturity assessment At one timepoint, a Hand radiograph is taken for digital skeletal maturity assessment |
- Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Girls: Baseline ]MRI images
- Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Girls: 11year ]MRI images
- Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Girls: 12year ]MRI images
- Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Girls: 13year ]MRI images
- Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Girls: 15year ]MRI images
- Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Boys: Baseline ]MRI images
- Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Boys: 12year ]MRI images
- Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Boys: 13year ]MRI images
- Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Boys: 14year ]MRI images
- Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Boys: 16year ]MRI images
- A-P ratio vertebrae and disc [ Time Frame: Girls: Baseline ]Ratio anterior and posterior height
- A-P ratio vertebrae and disc [ Time Frame: Girls: 11year ]Ratio anterior and posterior height
- A-P ratio vertebrae and disc [ Time Frame: Girls: 12year ]Ratio anterior and posterior height
- A-P ratio vertebrae and disc [ Time Frame: Girls: 13year ]Ratio anterior and posterior height
- A-P ratio vertebrae and disc [ Time Frame: Girls: 15year ]Ratio anterior and posterior height
- A-P ratio vertebrae and disc [ Time Frame: Boys: Baseline ]Ratio anterior and posterior height
- A-P ratio vertebrae and disc [ Time Frame: Boys: 12year ]Ratio anterior and posterior height
- A-P ratio vertebrae and disc [ Time Frame: Boys: 13year ]Ratio anterior and posterior height
- A-P ratio vertebrae and disc [ Time Frame: Boys: 14year ]Ratio anterior and posterior height
- A-P ratio vertebrae [ Time Frame: Boys: 16year ]Ratio anterior and posterior height
- Left-right ratio [ Time Frame: Girls: Baseline ]Ratio left and right height
- Left-right ratio [ Time Frame: Girls: 11year ]Ratio left and right height
- Left-right ratio [ Time Frame: Girls: 12year ]Ratio left and right height
- Left-right ratio [ Time Frame: Girls: 13year ]Ratio left and right height
- Left-right ratio [ Time Frame: Girls: 15year ]Ratio left and right height
- Left-right ratio [ Time Frame: Boys: Baseline ]Ratio left and right height
- Left-right ratio [ Time Frame: Boys: 12year ]Ratio left and right height
- Left-right ratio [ Time Frame: Boys: 13year ]Ratio left and right height
- Left-right ratio [ Time Frame: Boys: 14year ]Ratio left and right height
- Left-right ratio [ Time Frame: Boys: 16year ]Ratio left and right height
- Torsion [ Time Frame: Girls: Baseline ]Difference in axial rotation between 2 subsequent endplates
- Torsion [ Time Frame: Girls: 11year ]Difference in axial rotation between 2 subsequent endplates
- Torsion [ Time Frame: Girls: 12year ]Difference in axial rotation between 2 subsequent endplates
- Torsion [ Time Frame: Girls: 13year ]Difference in axial rotation between 2 subsequent endplates
- Torsion [ Time Frame: Girls: 15year ]Difference in axial rotation between 2 subsequent endplates
- Torsion [ Time Frame: Boys: Baseline ]Difference in axial rotation between 2 subsequent endplates
- Torsion [ Time Frame: Boys: 12year ]Difference in axial rotation between 2 subsequent endplates
- Torsion [ Time Frame: Boys: 13year ]Difference in axial rotation between 2 subsequent endplates
- Torsion [ Time Frame: Boys: 14year ]Difference in axial rotation between 2 subsequent endplates
- Torsion [ Time Frame: Boys: 16year ]Difference in axial rotation between 2 subsequent endplates
- Volumes disc [ Time Frame: Girls: Baseline ]Volumes disc
- Volumes disc [ Time Frame: Girls: 11year ]Volumes disc
- Volumes disc [ Time Frame: Girls: 12year ]Volumes disc
- Volumes disc [ Time Frame: Girls: 13year ]Volumes disc
- Volumes disc [ Time Frame: Girls: 15year ]Volumes disc
- Volumes disc [ Time Frame: Boys: Baseline ]Volumes disc
- Volumes disc [ Time Frame: Boys: 12year ]Volumes disc
- Volumes disc [ Time Frame: Boys: 13year ]Volumes disc
- Volumes disc [ Time Frame: Boys: 14year ]Volumes disc
- Volumes disc [ Time Frame: Boys: 16year ]Volumes disc
- Volumes vertebrae [ Time Frame: Girls: Baseline ]Volumes vertebrae
- Volumes vertebrae [ Time Frame: Girls: 11year ]Volumes vertebrae
- Volumes vertebrae [ Time Frame: Girls: 12year ]Volumes vertebrae
- Volumes vertebrae [ Time Frame: Girls: 13year ]Volumes vertebrae
- Volumes vertebrae [ Time Frame: Girls: 15year ]Volumes vertebrae
- Volumes vertebrae [ Time Frame: Boys: Baseline ]Volumes vertebrae
- Volumes vertebrae [ Time Frame: Boys: 12year ]Volumes vertebrae
- Volumes vertebrae [ Time Frame: Boys: 13year ]Volumes vertebrae
- Volumes vertebrae [ Time Frame: Boys: 14year ]Volumes vertebrae
- Volumes vertebrae [ Time Frame: Boys: 16year ]Volumes vertebrae
- Shift nucleus pulposis [ Time Frame: Girls: Baseline ]Position of nucleus pulposus in discus
- Shift nucleus pulposis [ Time Frame: Girls: 11year ]Position of nucleus pulposus in discus
- Shift nucleus pulposis [ Time Frame: Girls: 12year ]Position of nucleus pulposus in discus
- Shift nucleus pulposis [ Time Frame: Girls: 13year ]Position of nucleus pulposus in discus
- Shift nucleus pulposis [ Time Frame: Girls: 15year ]Position of nucleus pulposus in discus
- Shift nucleus pulposis [ Time Frame: Boys: Baseline ]Position of nucleus pulposus in discus
- Shift nucleus pulposis [ Time Frame: Boys: 12year ]Position of nucleus pulposus in discus
- Shift nucleus pulposis [ Time Frame: Boys: 13year ]Position of nucleus pulposus in discus
- Shift nucleus pulposis [ Time Frame: Boys: 14y ]Position of nucleus pulposus in discus
- Shift nucleus pulposis [ Time Frame: Boys: 16year ]Position of nucleus pulposus in discus
- Changes in spinal alignment during growth [ Time Frame: Girls: Baseline-15years, Boys: Baseline-15years ]Scan for changes over growth
- Spine specific maturity assessment grading [ Time Frame: Girls: Baseline-15years, Boys: Baseline-15years ]See if it is possible to create a spine specific maturity assessment
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Ages Eligible for Study: | 8 Years to 11 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05924347
Contact: Tom Schlosser | +31 88 75 53602 | t.p.c.schlosser@umcutrecht.nl | |
Contact: Hilde Stempels | h.w.stempels@umcutrecht.nl |
Netherlands | |
UMC Utrecht | Recruiting |
Utrecht, Netherlands, 3584 CX | |
Contact: Tom Schlösser, MD, PhD t.p.c.schlosser@umcutrecht.nl |
Responsible Party: | dr. Tom P.C. Schlösser, Principal Investigator, UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT05924347 |
Other Study ID Numbers: |
NL82419.041.22 |
First Posted: | June 29, 2023 Key Record Dates |
Last Update Posted: | June 29, 2023 |
Last Verified: | June 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Scoliosis DiGeorge Syndrome Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases 22q11 Deletion Syndrome Craniofacial Abnormalities Musculoskeletal Abnormalities Heart Defects, Congenital Cardiovascular Abnormalities |
Cardiovascular Diseases Heart Diseases Lymphatic Abnormalities Lymphatic Diseases Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn Hypoparathyroidism Parathyroid Diseases Endocrine System Diseases |