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临床试验/NCT05924347
NCT05924347招募中不适用

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.

UMC Utrecht1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
UMC Utrecht
入组人数
120
试验地点
1
主要终点
Spinal MR Imaging of the thoracic and lumbar spine

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 8, 9 or 10 years old
  • An older sibling, twin or parent diagnosed with AIS
  • Diagnosed with 22q11.2DS
  • Girls: 8, 9 or 10 years old.
  • Boys: 9, 10 or 11 years old.
  • 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.

排除标准

  • 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.

结局指标

主要结局

Spinal MR Imaging of the thoracic and lumbar spine

时间窗: Boys: 16year

MRI images

次要结局

  • Torsion(Boys: 16year)
  • Volumes vertebrae(Boys: 16year)
  • Shift nucleus pulposis(Boys: 16year)
  • Changes in spinal alignment during growth(Girls: Baseline-15years, Boys: Baseline-15years)
  • Volumes disc(Boys: 16year)
  • A-P ratio vertebrae and disc(Boys: 14year)
  • A-P ratio vertebrae(Boys: 16year)
  • Left-right ratio(Boys: 16year)
  • Spine specific maturity assessment grading(Girls: Baseline-15years, Boys: Baseline-15years)

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. Tom P.C. Schlösser

Principal Investigator

UMC Utrecht

研究点 (1)

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