A Prospective Study of Surgical Treatment Strategies for Goal B Type Basilar Invagination in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- JOA Score（Japanese Orthopaedic Association Scores）
研究概览
简要总结
The etiology of Goal B type basilar invagination (BI) is still not clear, and it may be related to platybasia and short slope. There is no unified standard surgical strategy for Goal B type BI, and different surgical strategies have a great influence on the surgical results of patients. The purpose of our prospective study in China is to (1) further clarify the etiology of Goal B type BI, and (2) improve the surgical outcome in these patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Goal B type basilar invagination (BI)
排除标准
- •Preoperative diagnosis was confirmed as not Goal B type basilar invagination (BI)
- •The patient was not physically fit for surgery.
结局指标
主要结局
JOA Score（Japanese Orthopaedic Association Scores）
时间窗: 1 months, 3 months, and 6 months postoperatively
Changes in JOA score，from 0 to 17, higher scores means better outcome
NDI Score
时间窗: 1 months, 3 months, and 6 months postoperatively
Changes in NDI score，from 0% to 100%，higher scores means worse outcome
次要结局
- Change of subarachnoid space(1 months, 3 months, and 6 months postoperatively)
- Change of Basilar Invagination(1 months, 3 months, and 6 months postoperatively)
- Change of CVJ triangle area(1 months, 3 months, and 6 months postoperatively)
- Change of CCA(1 months, 3 months, and 6 months postoperatively)
- Change of CMA(1 months, 3 months, and 6 months postoperatively)