跳至主要内容
临床试验/NCT02315729
NCT02315729招募中不适用

Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
380
试验地点
1
主要终点
Scoliosis Curve Progression

研究概览

简要总结

The purpose of this study is to identify potential markers for curve progression in adolescent idiopathic scoliosis (AIS). Despite its prevalence and impact on child health, the etiology of AIS and molecular mechanisms underlying its development and progression remain poorly understood. Clinical criteria and features cannot adequately predict which children, diagnosed with mild disease, will undergo subsequent curve progression requiring intervention.

The investigators hypothesize that alterations in specific genetic markers will be correlated with the progression of AIS curves over time. Thus, these markers could be used in the future to develop a reliable, inexpensive and relatively non-invasive cell based diagnostic test to (1) predict spinal curve progression in AIS, (2) select patients likely to benefit from early surgical intervention, and (3) potentially screen for asymptomatic children at risk of developing idiopathic scoliosis.

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
10 Years 至 13 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • Females aged 10-13 years
  • Diagnosed with mild-moderate spine deformity (Cobb angle 15-30 degrees)

排除标准

  • Patients with scoliosis other than idiopathic
  • Inflammatory disease
  • Malignancies
  • History of previous spine surgery

结局指标

主要结局

Scoliosis Curve Progression

时间窗: 3 years

Cobb angle, disc wedging, vertebral body wedging, coronal balance, sagittal balance

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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