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临床试验/NCT01336114
NCT01336114已完成不适用

A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
1
主要终点
Photographs of the back and spine radiographs for making a corset

研究概览

简要总结

Adolescent idiopathic scoliosis (AIS) involves complex tridimensional deformities of the spine. In case of progressive curve deformity, the use of spinal bracing remains the standard non operative treatment of moderate AIS. Most of the time, the different types of braces don't take into account the individual biomechanical properties of each patient's spine. Actually, it is essential to better understand the effect of the loads applied on the trunk and on the spine, and a 3D geometrical modelisation of these components is essential. Many studies have been publishing concerning the use of radiographs for the geometrical reconstruction of the spine, and more recently the EOS system. But even then, it is still necessary to obtain an important number of geometrical data and discretisation is still a long procedure.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
12 Years 至 15 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • Age ≥ 12 years
  • Pre menarchial for the girls
  • Risser 0 et Risser 3 on X rays. Radiologic classification of spine maturity (ossification of the iliac crests). Five stages.
  • Cobb angle ≥25° and < 40°
  • Information to the parents and child, and signed approval

排除标准

  • No idiopathic scoliosis
  • Previous brace treatment
  • Immediate indication for surgery
  • Previous thoracic surgery

结局指标

主要结局

Photographs of the back and spine radiographs for making a corset

时间窗: 3 years

The torso shape reconstruction is realized thanks to the system Model Maker(Proteor®) on adolescent idiopathic patients. Model Maker allows to reconstruct the external shape of the human body from about 20 images steaming from a standard digital camera.The spine reconstruction is has for her obtained by means of a software interface, from tow standard clinical X-rays in the digital format (frontal and sagittal) and images were used by Model Maker for the external shape reconstruction.

次要结局

  • Recording of pressure from the brace(3 years)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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