Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- The Number of Participants With Surgical Complications
研究概览
简要总结
The purpose of this study is to determine whether a posterior fossa decompression or a posterior fossa decompression with duraplasty results in better patient outcomes with fewer complications and improved quality of life in those who have Chiari malformation type I and syringomyelia.
详细描述
Participants with Chiari Malformation type I and syringomyelia will be randomized to either have a posterior fossa decompression done with or without duraplasty. The participant will then return to the neurosurgeon's office at the following time points which are consistent with standard of care practice: < 6 weeks, 3-6 months, and 12 months. At these visits, the clinician will complete a physical exam and the participant will report on the prognosis of symptoms and complete two quality of life questionnaires. A brain and cervical spine MRI will be performed 12 months after the decompression.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤21 years old
- •Chiari malformation type I ≥5 mm tonsillar ectopia
- •Syrinx between 3 mm and 6 mm
- •Chiari Severity Index (CSI) classification 1
- •MRI of the brain and cervical and thoracic spine are required prior to surgery and must be available to be shared with the Data Coordinating Center
排除标准
- •CSI-2 or CSI-3 classification
- •Syrinx <3 mm and/or ≥6 mm
- •Neuro-imaging demonstrating basilar invagination
- •Clival canal angle <120° (signs of severe craniovertebral junction disease)
- •Chiari Malformation I + syringomyelia secondary to other pathology (e.g. a tumor)
- •Unable to share pre-decompression MRI of the brain and cervical and thoracic spine
- •Patients who do not wish to participate
结局指标
主要结局
The Number of Participants With Surgical Complications
时间窗: less then or equal to 6 months from decompression
The number of participants with complications such as: Cerebrospinal fluid (CSF)-related complications ≤6 months (e.g. CSF leak, pseudomeningocele, aseptic meningitis, infection, hydrocephalus), and the requirement for additional surgery for wound revision or CSF diversion
次要结局
- Aim 2: The Number of Patients With Clinical Improvement(10-14 months)
- Aim 2: The Mean Number of Syrinx Reduction in Millimeters Less Than 24 Months Post Surgery.(10-14 months)