NCT00955565已完成4 期
Accuracy of Navigation in Placement of Sacroiliac Screw. Multicenter Randomized Controlled Trial
AO Clinical Investigation and Publishing Documentation17 个研究点 分布在 3 个国家目标入组 150 人开始时间: 2008年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 17
- 主要终点
- Proportion of misplaced sacroiliac screws as evaluated by postop CT-scanning.
研究概览
简要总结
The purpose of this study is to compare the precision of computer-assisted navigation for hip screw implantation to conventional fixation without navigation.
详细描述
Standard treatment for sacroiliac dislocations and sacroiliac fractures is placement of two screws through the iliosacral joint into the sacral ala or the body of the S1 vertebra. Correct positioning is technically demanding. Screw displacement may reduce the strength of fixation and lead to neurological complications.
Secondary objectives of the study are to compare the fluoroscopy time, complications and surgery duration between the treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Radiologically confirmed sacroiliac dislocation or sacroiliac fracture
- •Sacroiliac arthritis
- •Age 18 years and more
- •Written informed consent by patient or his/her legal representative
排除标准
- •Poor life expectancy (<3months)
- •Fracture of pathologic origin
- •History of substance abuse (recreational drugs, alcohol)within 12 months prior to screening
- •Currently involved in another study that precludes or complicates participation
- •Disease or condition that would preclude accurate evaluation (e.g., significant psychiatric disease)
结局指标
主要结局
Proportion of misplaced sacroiliac screws as evaluated by postop CT-scanning.
时间窗: 2 days
次要结局
- Fluoroscopic time, complications and surgery duration.(2 days)
研究者
研究点 (17)
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