NCT00283998已完成4 期
Phase 4 Study Comparing Surigcal to Conservative Management of Type 2 Odontoid Fractures
AO Clinical Investigation and Publishing Documentation2 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2006年1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
- 166
- 试验地点
- 2
- 主要终点
- Quality of life using the Neck disability Index
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients >/= 65 years of age. Of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All new type II odontoid fractures including < those in which the fracture line crosses into the body of C2 < as long as it doesn't enter the superior articular process of C2
- •Stable and unstable fractures
- •< 3 months postinjury
- •No previous treatment for an odontoid fracture
排除标准
- •Pathologic fractures unrelated to osteoporosis
- •Severe dementia or other severe mental health problem if there is no consentable surrogate available
- •Participating in other trials or unlikely to attend follow-ups
结局指标
主要结局
Quality of life using the Neck disability Index
时间窗: 12 months
Quality of life using the SF-36
时间窗: 12 months
Proportion of bony fusion between the two treatments
时间窗: 6 months
Proportion rate of non-union between the two treatments
时间窗: 6 months
次要结局
- Rate of complications(12 months)
- Cervical range of motion(12 months)
- Identify the risk factors for a poor outcome independent of treatment intervention(12 months)
研究者
研究点 (2)
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