Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05924347
Other study ID # NL82419.041.22
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 16, 2023
Est. completion date May 1, 2032

Study information

Verified date June 2023
Source UMC Utrecht
Contact Tom Schlosser
Phone +31 88 75 53602
Email t.p.c.schlosser@umcutrecht.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 120
Est. completion date May 1, 2032
Est. primary completion date May 2032
Accepts healthy volunteers No
Gender All
Age group 8 Years to 11 Years
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
MRI
Longitudinal MRI examination of the thoracic and lumbar spine (T2, T2w, sCT)
Scolioscan
3D ultrasound of the spine
Skeletal maturity assessment
At one timepoint, a Hand radiograph is taken for digital skeletal maturity assessment

Locations

Country Name City State
Netherlands UMC Utrecht Utrecht

Sponsors (2)

Lead Sponsor Collaborator
UMC Utrecht Eindhoven University of Technology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Spinal MR Imaging of the thoracic and lumbar spine MRI images Girls: Baseline
Primary Spinal MR Imaging of the thoracic and lumbar spine MRI images Girls: 11year
Primary Spinal MR Imaging of the thoracic and lumbar spine MRI images Girls: 12year
Primary Spinal MR Imaging of the thoracic and lumbar spine MRI images Girls: 13year
Primary Spinal MR Imaging of the thoracic and lumbar spine MRI images Girls: 15year
Primary Spinal MR Imaging of the thoracic and lumbar spine MRI images Boys: Baseline
Primary Spinal MR Imaging of the thoracic and lumbar spine MRI images Boys: 12year
Primary Spinal MR Imaging of the thoracic and lumbar spine MRI images Boys: 13year
Primary Spinal MR Imaging of the thoracic and lumbar spine MRI images Boys: 14year
Primary Spinal MR Imaging of the thoracic and lumbar spine MRI images Boys: 16year
Secondary A-P ratio vertebrae and disc Ratio anterior and posterior height Girls: Baseline
Secondary A-P ratio vertebrae and disc Ratio anterior and posterior height Girls: 11year
Secondary A-P ratio vertebrae and disc Ratio anterior and posterior height Girls: 12year
Secondary A-P ratio vertebrae and disc Ratio anterior and posterior height Girls: 13year
Secondary A-P ratio vertebrae and disc Ratio anterior and posterior height Girls: 15year
Secondary A-P ratio vertebrae and disc Ratio anterior and posterior height Boys: Baseline
Secondary A-P ratio vertebrae and disc Ratio anterior and posterior height Boys: 12year
Secondary A-P ratio vertebrae and disc Ratio anterior and posterior height Boys: 13year
Secondary A-P ratio vertebrae and disc Ratio anterior and posterior height Boys: 14year
Secondary A-P ratio vertebrae Ratio anterior and posterior height Boys: 16year
Secondary Left-right ratio Ratio left and right height Girls: Baseline
Secondary Left-right ratio Ratio left and right height Girls: 11year
Secondary Left-right ratio Ratio left and right height Girls: 12year
Secondary Left-right ratio Ratio left and right height Girls: 13year
Secondary Left-right ratio Ratio left and right height Girls: 15year
Secondary Left-right ratio Ratio left and right height Boys: Baseline
Secondary Left-right ratio Ratio left and right height Boys: 12year
Secondary Left-right ratio Ratio left and right height Boys: 13year
Secondary Left-right ratio Ratio left and right height Boys: 14year
Secondary Left-right ratio Ratio left and right height Boys: 16year
Secondary Torsion Difference in axial rotation between 2 subsequent endplates Girls: Baseline
Secondary Torsion Difference in axial rotation between 2 subsequent endplates Girls: 11year
Secondary Torsion Difference in axial rotation between 2 subsequent endplates Girls: 12year
Secondary Torsion Difference in axial rotation between 2 subsequent endplates Girls: 13year
Secondary Torsion Difference in axial rotation between 2 subsequent endplates Girls: 15year
Secondary Torsion Difference in axial rotation between 2 subsequent endplates Boys: Baseline
Secondary Torsion Difference in axial rotation between 2 subsequent endplates Boys: 12year
Secondary Torsion Difference in axial rotation between 2 subsequent endplates Boys: 13year
Secondary Torsion Difference in axial rotation between 2 subsequent endplates Boys: 14year
Secondary Torsion Difference in axial rotation between 2 subsequent endplates Boys: 16year
Secondary Volumes disc Volumes disc Girls: Baseline
Secondary Volumes disc Volumes disc Girls: 11year
Secondary Volumes disc Volumes disc Girls: 12year
Secondary Volumes disc Volumes disc Girls: 13year
Secondary Volumes disc Volumes disc Girls: 15year
Secondary Volumes disc Volumes disc Boys: Baseline
Secondary Volumes disc Volumes disc Boys: 12year
Secondary Volumes disc Volumes disc Boys: 13year
Secondary Volumes disc Volumes disc Boys: 14year
Secondary Volumes disc Volumes disc Boys: 16year
Secondary Volumes vertebrae Volumes vertebrae Girls: Baseline
Secondary Volumes vertebrae Volumes vertebrae Girls: 11year
Secondary Volumes vertebrae Volumes vertebrae Girls: 12year
Secondary Volumes vertebrae Volumes vertebrae Girls: 13year
Secondary Volumes vertebrae Volumes vertebrae Girls: 15year
Secondary Volumes vertebrae Volumes vertebrae Boys: Baseline
Secondary Volumes vertebrae Volumes vertebrae Boys: 12year
Secondary Volumes vertebrae Volumes vertebrae Boys: 13year
Secondary Volumes vertebrae Volumes vertebrae Boys: 14year
Secondary Volumes vertebrae Volumes vertebrae Boys: 16year
Secondary Shift nucleus pulposis Position of nucleus pulposus in discus Girls: Baseline
Secondary Shift nucleus pulposis Position of nucleus pulposus in discus Girls: 11year
Secondary Shift nucleus pulposis Position of nucleus pulposus in discus Girls: 12year
Secondary Shift nucleus pulposis Position of nucleus pulposus in discus Girls: 13year
Secondary Shift nucleus pulposis Position of nucleus pulposus in discus Girls: 15year
Secondary Shift nucleus pulposis Position of nucleus pulposus in discus Boys: Baseline
Secondary Shift nucleus pulposis Position of nucleus pulposus in discus Boys: 12year
Secondary Shift nucleus pulposis Position of nucleus pulposus in discus Boys: 13year
Secondary Shift nucleus pulposis Position of nucleus pulposus in discus Boys: 14y
Secondary Shift nucleus pulposis Position of nucleus pulposus in discus Boys: 16year
Secondary Changes in spinal alignment during growth Scan for changes over growth Girls: Baseline-15years, Boys: Baseline-15years
Secondary Spine specific maturity assessment grading See if it is possible to create a spine specific maturity assessment Girls: Baseline-15years, Boys: Baseline-15years
See also
  Status Clinical Trial Phase
Recruiting NCT03935295 - Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis Phase 4
Recruiting NCT06262269 - Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents N/A
Not yet recruiting NCT06003010 - Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients N/A
Withdrawn NCT02590380 - Comparing Pedicle Screw Systems for the Treatment of Adolescent Paediatric Spine Deformity N/A
Completed NCT02302534 - Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA) N/A
Completed NCT05669859 - Efficacy of Postoperative Telerehabilitation in Adolescent Idiopathic Scoliosis N/A
Completed NCT05242601 - Investigation of Quality of Life in Adolescent Idiopathic Scoliosis
Recruiting NCT05969301 - Memory and Scoliosis Spinal Exercises
Recruiting NCT05919459 - Effectiveness of Acceptance and Commitment Therapy Versus Active Controls in Improving Psychological Functions of Parents and Children With Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial N/A
Enrolling by invitation NCT05790031 - Trials of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis N/A
Active, not recruiting NCT04867148 - The Prediction and Prevention of Disease by Using Big Data in Motion Analysis N/A
Completed NCT05056363 - The Effects of Core Stability Training in Children With Adolescent Idiopathic Scoliosis N/A
Completed NCT00989495 - Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study N/A
Withdrawn NCT00958373 - Risk Factors for Psychiatric Disorders Associated With Adolescent Idiopathic Scoliosis N/A
Recruiting NCT05730920 - IV Methadone vs EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Idiopathic Scoliosis Correction Phase 4
Recruiting NCT03292601 - Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS) N/A
Completed NCT04421157 - Exercises in Adolescent Idiopathic Scoliosis N/A
Completed NCT05127902 - Association Between Postural Balance and Muscle Activity of the Lumbar and Lower Limb Muscles in Female With or Without Adolescent Idiopathic Scoliosis (AIS) During Standing Balance Tasks With Upper Limb Movement
Completed NCT05703737 - Respiratory Function and Respiratory Muscle Strength in Adolescent Idiopathic Scoliosis
Completed NCT04092335 - Evaluation of Adam's Forward Bend Test and Smartphone Application in Screening of Adolescent Idiopathic Scoliosis