NCT01335841已完成3 期
Evaluation of an 3D Imaging Intensifier Coupled to a Navigation Station in the Surgery of the Spine and Pelvis
AdministrateurCIC1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM
研究概览
简要总结
The purpose of this study is to demonstrate an optimization of the establishment of orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and navigation system versus conventional method involving anatomical landmarks and 2D fluoroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged over 18 years old
- •Patient affiliated to social security or similarly regime
- •Patient with a disease of the pelvic ring, with an indication of establishment of a screw sacro-iliac
- •Patient with a disease of the spine, with an indication of establishment of pedicle implant
排除标准
- •Intubated patient resuscitation
- •Pregnant women and lactating mothers
- •Adult unable to express their consent
- •Ward of court or under guardianship
- •Person under legal protection
- •Person deprived of freedom by judicial or administrative decision
- •Person hospitalized without their consent
结局指标
主要结局
Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM
时间窗: two years
次要结局
- measure radiation of the surgeon and the patient in the two groups(two years)
- Show that the operative time is not increased significantly taking into account the learning curve and the benefit provided from a conventional 2-D amplifier(two years)
研究者
AdministrateurCIC
principal investigator
University Hospital, Grenoble
研究点 (1)
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