Dynamic Decompressive Craniotomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Clinical outcome
研究概览
简要总结
Prospective observational study on patients undergoing decompressive craniotomy
详细描述
A prospective study of 20 neurosurgical patients evaluating the dynamic decompressive craniotomy technique using NeuroVention, LLC craniotomy bone flap fixation plates. The plates allow for rigid and semi-rigid bone flap fixation dependent on the implantation technique. A dynamic craniotomy involves bone flap fixation wherein a limited transient outward bone flap movement is allowed by the plates to compensate for an increase in intracranial pressure from brain swelling. The plates also prevent the craniotomy bone flap from sinking inside the skull and compressing on the brain. Cerebral decompression surgery is undertaken for patients with cerebral swelling from malignant strokes, medically intractable intracranial pressure elevation in traumatic brain injuries and brain tumors. The dynamic craniotomy technique eliminates or reduces the need for a cranioplasty surgery with a potentially significant improvement in outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from a malignant stroke
- •Patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from traumatic brain injury
- •Patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from brain tumors.
排除标准
- •Patients with blown pupil (cerebral herniation),
- •Massive brain swelling
- •Dismal outcome not expected to survive more than 1-2 weeks.
结局指标
主要结局
Clinical outcome
时间窗: 6 months
Modified Rankin Scale and Glasgow Outcome Score
Craniotomy bone flap healing
时间窗: 3 months
CT scan to assess rate of normal bone flap position
次要结局
未报告次要终点
研究者
Rohit Khanna, MD
Principal Investigator
NeuroVention, LLC