PARAMETRES GLOBAUX DE REFERENCE DU RACHIS CALCULES SUR DES PATIENTS ASYMPTOMATIQUES PAR IMAGERIE EOS™
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- the pelvis parameters
研究概览
简要总结
The lumbar pain caring consists from a 3D reconstruction of the spine obtained to scan or radiography, determining the lumbar pain cause and gravity, to propose a conservative treatment in first intention or a adapted spine surgery in first or second intention (Fritzell and al ., on 2001).
The analysis and the correction of postural disorders pass inevitably by a good knowledge of the not pathological posture. The validation of the acquisition 2D / 3D reconstruction by EOS ™ technology demonstrated its interest for the diagnosis and the lumbar pain caring.
However, the EOS technology ™ is recent and few data were acquired with this technology for healthy population.
So, this clinical study with EOS ™technology would allow to obtain a precise knowledge of the standing skeleton in position (to an asymptomatic adult population), by displaying the gravity constraints on the joints, and the compensation phenomena in normal situation. This functional information for a given age bracket would allow to propose to the patients with lumbar pain, adapted interventions to the gravity constraints considering the skeleton evolution for age bracket.
详细描述
The main objective of this study is to describe thoraco-lumbar spine characteristics, obtained by EOS ™technology, in a reference population, not presenting spine pathology. It's a monocentric transverse descriptive study. This study allows creating a database of the spine, pelvis and sagittal balance parameters to asymptomatic subjects according to age brackets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of more than 18 years old
- •Both genders
- •Woman under efficient contraception (if not menopause)
- •EVA < 2 for the rachis (lumbar vertebra and radiculaire),
- •Score ODI ≤ 20 %
- •Given informed consent
- •Subject with French health system
排除标准
- •Pregnant or feeding women
- •Subject having a follow-up of the back or a regular back pain,
- •Subject presenting lower limbs pathology which can have an echo on the rachis such as a length disparity or a flexum
- •Subject with spine and pelvis surgery antecedents.
- •Person placed under protection of justice
结局指标
主要结局
the pelvis parameters
时间窗: 1 day
the profile spine parameters: apex lumbar position
时间窗: 1 day
the lordosis lower angle, back type according to the ROUSSOULY
时间窗: 1 day
the sagittal balance parameters
时间窗: 1 day
the lordosis upper angle, back type according to the ROUSSOULY
时间窗: 1 day
次要结局
未报告次要终点