Actively Recruiting

Age: 8Years - 11Years
All Genders
NCT05924347

Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development

Led by UMC Utrecht · Updated on 2023-06-29

120

Participants Needed

1

Research Sites

463 weeks

Total Duration

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Sponsors

U

UMC Utrecht

Lead Sponsor

E

Eindhoven University of Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development

Who Can Participate

Age: 8Years - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UMC Utrecht

Utrecht, Netherlands, 3584 CX

Actively Recruiting

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Research Team

T

Tom Schlosser

CONTACT

H

Hilde Stempels

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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