Bioactive Glass Composite Implants in Cranial Bone Reconstruction
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Clinical success
研究概览
简要总结
The purpose of this study is to study composites of bioactive glass and methylmetacrylate with glass fibre reinforcement in cranial bone defect reconstruction.
详细描述
Traditional skull and facial bone reconstructions with hard tissues have a long history with good clinical outcomes. However, they have certain disadvantages. The benefits of synthetic materials are the avoidance of donor-site morbidity and scars, but also shorter hospitalization time, lower expenses and known composition. Custom-made skull bone implant can produced based on patients clinical need utilizing rapid prototyping technologies. This will result in very high accuracy of the form of the skull defect.
Polymethylmetacrylate (PMMA) is one of the most widely used alloplastic material in surgery. Bioactive glass S53P4 (BAG) particles have been used in various clinical indications. BAG was added to composite implant of PMMA with glass fibre reinforcement to enhance bone ingrowth to implant, and to utilize BAG's antimicrobial effects. Ten patients cranial defects are treated with composite implants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 with cranial bone defect larger than 4x4 cm after trauma or tumor surgery
- •patient signs written study consent
排除标准
- •patient is unlikely to adhere to study procedures
- •patient has a disease or condition that in the opinion of investigator is contraindicating participation
- •patient is participating another medical device or drug trial
结局指标
主要结局
Clinical success
时间窗: 3 years
Clinical success is evaluated using clinical and radiographic examination, and blood count.
次要结局
未报告次要终点