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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
Sponsor:
Collaborator:
Eindhoven University of Technology
Information provided by (Responsible Party):
dr. Tom P.C. Schlösser, UMC Utrecht

Study Description
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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.

Condition or disease Intervention/treatment
Adolescent Idiopathic Scoliosis 22q11.2 Deletion Syndrome Diagnostic Test: MRI Diagnostic Test: Scolioscan Diagnostic Test: Skeletal maturity assessment

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.

Study Design
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Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Groups and Cohorts
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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)
 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


Outcome Measures
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Primary Outcome Measures :
  1. Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Girls: Baseline ]
    MRI images

  2. Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Girls: 11year ]
    MRI images

  3. Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Girls: 12year ]
    MRI images

  4. Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Girls: 13year ]
    MRI images

  5. Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Girls: 15year ]
    MRI images

  6. Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Boys: Baseline ]
    MRI images

  7. Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Boys: 12year ]
    MRI images

  8. Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Boys: 13year ]
    MRI images

  9. Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Boys: 14year ]
    MRI images

  10. Spinal MR Imaging of the thoracic and lumbar spine [ Time Frame: Boys: 16year ]
    MRI images


Secondary Outcome Measures :
  1. A-P ratio vertebrae and disc [ Time Frame: Girls: Baseline ]
    Ratio anterior and posterior height

  2. A-P ratio vertebrae and disc [ Time Frame: Girls: 11year ]
    Ratio anterior and posterior height

  3. A-P ratio vertebrae and disc [ Time Frame: Girls: 12year ]
    Ratio anterior and posterior height

  4. A-P ratio vertebrae and disc [ Time Frame: Girls: 13year ]
    Ratio anterior and posterior height

  5. A-P ratio vertebrae and disc [ Time Frame: Girls: 15year ]
    Ratio anterior and posterior height

  6. A-P ratio vertebrae and disc [ Time Frame: Boys: Baseline ]
    Ratio anterior and posterior height

  7. A-P ratio vertebrae and disc [ Time Frame: Boys: 12year ]
    Ratio anterior and posterior height

  8. A-P ratio vertebrae and disc [ Time Frame: Boys: 13year ]
    Ratio anterior and posterior height

  9. A-P ratio vertebrae and disc [ Time Frame: Boys: 14year ]
    Ratio anterior and posterior height

  10. A-P ratio vertebrae [ Time Frame: Boys: 16year ]
    Ratio anterior and posterior height

  11. Left-right ratio [ Time Frame: Girls: Baseline ]
    Ratio left and right height

  12. Left-right ratio [ Time Frame: Girls: 11year ]
    Ratio left and right height

  13. Left-right ratio [ Time Frame: Girls: 12year ]
    Ratio left and right height

  14. Left-right ratio [ Time Frame: Girls: 13year ]
    Ratio left and right height

  15. Left-right ratio [ Time Frame: Girls: 15year ]
    Ratio left and right height

  16. Left-right ratio [ Time Frame: Boys: Baseline ]
    Ratio left and right height

  17. Left-right ratio [ Time Frame: Boys: 12year ]
    Ratio left and right height

  18. Left-right ratio [ Time Frame: Boys: 13year ]
    Ratio left and right height

  19. Left-right ratio [ Time Frame: Boys: 14year ]
    Ratio left and right height

  20. Left-right ratio [ Time Frame: Boys: 16year ]
    Ratio left and right height

  21. Torsion [ Time Frame: Girls: Baseline ]
    Difference in axial rotation between 2 subsequent endplates

  22. Torsion [ Time Frame: Girls: 11year ]
    Difference in axial rotation between 2 subsequent endplates

  23. Torsion [ Time Frame: Girls: 12year ]
    Difference in axial rotation between 2 subsequent endplates

  24. Torsion [ Time Frame: Girls: 13year ]
    Difference in axial rotation between 2 subsequent endplates

  25. Torsion [ Time Frame: Girls: 15year ]
    Difference in axial rotation between 2 subsequent endplates

  26. Torsion [ Time Frame: Boys: Baseline ]
    Difference in axial rotation between 2 subsequent endplates

  27. Torsion [ Time Frame: Boys: 12year ]
    Difference in axial rotation between 2 subsequent endplates

  28. Torsion [ Time Frame: Boys: 13year ]
    Difference in axial rotation between 2 subsequent endplates

  29. Torsion [ Time Frame: Boys: 14year ]
    Difference in axial rotation between 2 subsequent endplates

  30. Torsion [ Time Frame: Boys: 16year ]
    Difference in axial rotation between 2 subsequent endplates

  31. Volumes disc [ Time Frame: Girls: Baseline ]
    Volumes disc

  32. Volumes disc [ Time Frame: Girls: 11year ]
    Volumes disc

  33. Volumes disc [ Time Frame: Girls: 12year ]
    Volumes disc

  34. Volumes disc [ Time Frame: Girls: 13year ]
    Volumes disc

  35. Volumes disc [ Time Frame: Girls: 15year ]
    Volumes disc

  36. Volumes disc [ Time Frame: Boys: Baseline ]
    Volumes disc

  37. Volumes disc [ Time Frame: Boys: 12year ]
    Volumes disc

  38. Volumes disc [ Time Frame: Boys: 13year ]
    Volumes disc

  39. Volumes disc [ Time Frame: Boys: 14year ]
    Volumes disc

  40. Volumes disc [ Time Frame: Boys: 16year ]
    Volumes disc

  41. Volumes vertebrae [ Time Frame: Girls: Baseline ]
    Volumes vertebrae

  42. Volumes vertebrae [ Time Frame: Girls: 11year ]
    Volumes vertebrae

  43. Volumes vertebrae [ Time Frame: Girls: 12year ]
    Volumes vertebrae

  44. Volumes vertebrae [ Time Frame: Girls: 13year ]
    Volumes vertebrae

  45. Volumes vertebrae [ Time Frame: Girls: 15year ]
    Volumes vertebrae

  46. Volumes vertebrae [ Time Frame: Boys: Baseline ]
    Volumes vertebrae

  47. Volumes vertebrae [ Time Frame: Boys: 12year ]
    Volumes vertebrae

  48. Volumes vertebrae [ Time Frame: Boys: 13year ]
    Volumes vertebrae

  49. Volumes vertebrae [ Time Frame: Boys: 14year ]
    Volumes vertebrae

  50. Volumes vertebrae [ Time Frame: Boys: 16year ]
    Volumes vertebrae

  51. Shift nucleus pulposis [ Time Frame: Girls: Baseline ]
    Position of nucleus pulposus in discus

  52. Shift nucleus pulposis [ Time Frame: Girls: 11year ]
    Position of nucleus pulposus in discus

  53. Shift nucleus pulposis [ Time Frame: Girls: 12year ]
    Position of nucleus pulposus in discus

  54. Shift nucleus pulposis [ Time Frame: Girls: 13year ]
    Position of nucleus pulposus in discus

  55. Shift nucleus pulposis [ Time Frame: Girls: 15year ]
    Position of nucleus pulposus in discus

  56. Shift nucleus pulposis [ Time Frame: Boys: Baseline ]
    Position of nucleus pulposus in discus

  57. Shift nucleus pulposis [ Time Frame: Boys: 12year ]
    Position of nucleus pulposus in discus

  58. Shift nucleus pulposis [ Time Frame: Boys: 13year ]
    Position of nucleus pulposus in discus

  59. Shift nucleus pulposis [ Time Frame: Boys: 14y ]
    Position of nucleus pulposus in discus

  60. Shift nucleus pulposis [ Time Frame: Boys: 16year ]
    Position of nucleus pulposus in discus

  61. Changes in spinal alignment during growth [ Time Frame: Girls: Baseline-15years, Boys: Baseline-15years ]
    Scan for changes over growth

  62. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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) Cohort 2: 60 adolescent girls or boys with the 22q11.2DS with increased risk for idiopathic-like scoliosis development.
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Tom Schlosser +31 88 75 53602 t.p.c.schlosser@umcutrecht.nl
Contact: Hilde Stempels h.w.stempels@umcutrecht.nl

Locations
Layout table for location information
Netherlands
UMC Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Tom Schlösser, MD, PhD       t.p.c.schlosser@umcutrecht.nl   
Sponsors and Collaborators
UMC Utrecht
Eindhoven University of Technology
More Information
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Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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