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.

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 11
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Netherlands
UMC Utrecht
RECRUITING
Utrecht
Contact Information
Primary
Tom Schlosser
t.p.c.schlosser@umcutrecht.nl
+31 88 75 53602
Backup
Hilde Stempels
h.w.stempels@umcutrecht.nl
Time Frame
Start Date: 2023-06-16
Estimated Completion Date: 2032-05-01
Participants
Target number of participants: 120
Treatments
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.
Sponsors
Collaborators: Eindhoven University of Technology
Leads: UMC Utrecht

This content was sourced from clinicaltrials.gov