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
- NDI Score
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.
研究组 & 干预措施
Posterior fossa decompression
Posterior arch of atlas removal, reconstruction of cisterna magna, decompression of cerebellum, detection of magendie foramen.
干预措施: Posterior fossa decompression (Procedure)
Posterior Compression-Distraction-Reduction-Fixation
After subperiosteal dissection, the facet joint was exposed. A 2-mm joint "scraper" with sharp edge was inserted into the joint capsule and rotated to remove the articular cartilage. A blunt-edged rotating distractor was then inserted into the joint space, and the facet was sequentially opened with larger and larger blunt rotating distractors. After distraction on one side, an appropriate-sized trial was placed into the contralateral facet, holding the distraction open. This was repeated back and forth with larger trials. These steps were repeated, and the facet joints were distracted up to the pre-planned distance of the odontoid tip above Chamberlain's line.
干预措施: Posterior Compression-Distraction-Reduction-Fixation (Procedure)
结局指标
主要结局
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
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
次要结局
- 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 subarachnoid space(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)