NCT00266929已完成不适用
Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
AOSpine North America Research Network15 个研究点 分布在 2 个国家目标入组 159 人开始时间: 2005年12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
- 159
- 试验地点
- 15
- 主要终点
- Compare disease-specific health-related quality of life between the surgically and conservatively managed patients 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 > 64 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.
详细描述
Hypotheses are as follows:
- Patients receiving surgical management will exhibit better disease specific health and general health related quality of life measures compared to those managed conservatively.
- The rate of radiographic bony fusion will be greater among elderly patients receiving surgical fixation compared to patients receiving conservative management.
- The rate of non union will be greater in the conservative group compared to the surgical group.
- The complication rate will be higher in the surgical group due to the nature of the intervention though the rate of severe and serious complications will be low.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 64 Years 至 —（Adult, 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
- •Age > 64
- •Stable and unstable fractures
- •< 3 months post-injury
- •No previous treatment for an odontoid fracture
排除标准
- •Pathological fractures unrelated to osteoporosis
- •Severe dementia or severe mental health problems
- •Participation in other trials or unlikely to attend follow-ups
结局指标
主要结局
Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index
时间窗: 12 months
Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients
时间窗: 12 months
Compare the rate of non-union between the surgically and conservatively managed patients
时间窗: 12 months
次要结局
- Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management(12 months)
- Identify risk factors for a poor outcome, independent of treatment intervention(12 months)
- Compare the rate of complications(12 months)
研究者
研究点 (15)
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