A Prospective Study of Natural History and Clinical Outcomes for Basilar Invagination
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- operation complication
研究概览
简要总结
A Prospective Study of Natural History and Clinical Outcomes for Basilar Invagination
详细描述
Since basilar invagination was reported, its pathogenesis has been considered both primary and secondary. Surgical treatment methods emerged in an endless stream, and a hundred schools of thought contend. However, the link between the symptoms and imaging has not been studied in detail. We prospectively enrolled patients with basilar depression, and then explored the natural history of the disease and the clinical outcomes of early intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BI discovered by the patient not incidentally;
- •Patients with depression of the skull base caused by congenital skeletal developmental malformations and symptoms;
- •The patient was initially treated in our center, and the interval between onset and treatment was at least 1 month or no treatment;
- •The imaging diagnosis of BI meets the standard (3-5mm higher than the Chamberlain's line)
排除标准
- •secondary BI caused by trauma, pathological factors such as rheumatoid arthritis, hyperparathyroidism, osteogenesis imperfecta, rickets, osteomalacia, spinal cord tumors, tuberculosis, inflammation of adjacent structures, and simple AAD, odontoid body deformity, etc.
- •spinal vascular disease, intervertebral disc herniation, tethered spinal cord disease and other diseases that may cause symptoms.
- •Patients with incomplete imaging data or symptomatic data.
结局指标
主要结局
operation complication
时间窗: 6 months postoperatively
operation complication（Excessive bleeding, bronchopneumonia, vertebral artery injury ）
improved symptoms
时间窗: 6 months postoperatively
The symptoms improved after the opration or natural condition.（JOA scores and SF-12 scores）
improved radiology
时间窗: 6 months postoperatively
improved ADI, CCA, CTA ; The basilar invagination reduced
次要结局
未报告次要终点