Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy of the "Skull Grip" new system of cranial flap fixation
研究概览
简要总结
Bone flaps after craniotomy are typically fixed with suture material, mini plates and others devices. In some cases, fixation with suture material is not secure as it may result in shifting of the bone flap with its dislocation. We will test the safety and efficacy of SKULL GRIP a new device for fixation of the bone flap during cranial procedure comparing to traditional suture materials.
详细描述
At the end of the operation to start the fixation of cranial bone flaps, at least three Skull Grip titanium clamps will be positioned equidistant to one another along the craniotomy opening. The lower parts (complete circle) will be inserted between the dura and the cranium. The linear parts of the superior semicircle have to be in line with the craniotomy borders to allow the lodging of the bone flap. The different heights of the device are finalized to suit it for the different thickness of the cranial vault. The same procedure will be performed with all remaining Skull Grip titanium clamps.The bone flap will be then placed in its original position. By using a forceps, a simple and easy clockwise rotation of the superior semicircle will allow to block the SKULL GRIP clamp in place. For simple removal if necessary of the Skull Grip titanium clamps, even if bone ossification of the craniotomy edges has already occurred, it will be necessary just to lift up the superior semicircle of the Skull Grip by a forceps and to cut by a cutting forceps the pin between the two circle. Then, craniotomy could be completed in a standard way.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major patient (aged ≥ 18 years)
- •Patient scheduled for craniotomy for a benign tumor
- •Patient informed and have signed informed consent
排除标准
- •Patient not affiliated with a social security scheme (or beneficiary entitled)
- •Patient with a known allergy to titanium
- •Patient non-compliant or whose follow-up to 3 months is impossible
- •Patient with against-indication scanner
- •Pregnant or lactating
结局指标
主要结局
To evaluate the efficacy of the "Skull Grip" new system of cranial flap fixation
时间窗: 2009
次要结局
- To evaluate the security of "Skull Grip" new system of cranial flap fixation(2009)
- Compare functional benefits (ease and speed of implementation) of "Skull Grip" new system of cranial flap fixation compared with traditional sutures(2009)