A Randomized Controlled Trial for Surgical Treatment of Reducible Atlantoaxial Dislocation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 164
- 主要终点
- Fusion Rates
研究概览
简要总结
The management of reducible atlantoaxial dislocation associated is challenging. Direct posterior distraction technique we proposed in 2010 could achieve satisfactory reduction. In 2020, we modified this technique and proposed a posterior intra-articular distraction technique. The intra-articular distraction technique could theoretically achieve satisfactory reduction and fusion. However, its superiority has not been proven. Therefore, we design a RCT study to compare the reduction rate and fusion rate of different strategies.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CT indicated atlantoaxial dislocation Agree with the operation plan Agree to be followed up
排除标准
- •The pathology is traumatic or RA Underwent operations in occipital-cervical region before With mortal diseases Without ability to sign papers
研究组 & 干预措施
Intra-articular Group
Posterior intra-articular distraction and fusion
干预措施: Intra-articular Cages (Device)
Posterior Group
Posterior direct distraction and fusion
结局指标
主要结局
Fusion Rates
时间窗: 12 months
Atlantoaixal fusion rates
次要结局
- Visual Analogue Scale(12 months)
- Neck Disability Index(12 months)
- Japanese Orthopaedic Association Scores(12 months)
