NCT01282645撤回不适用
A Retrospective Case Series to Evaluate the Long Term Outcome of the Use of Synthes Patient Specific Implants (PSI®) Made of Polyether Ether Ketone (PEEK) for the Treatment of Cranial Defects in Patients With a Mature Skeleton
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Synthes GmbH
- 试验地点
- 30
- 主要终点
- Device related adverse events
研究概览
简要总结
The primary objective of this retrospective study is to evaluate the percentage of patients with device related adverse events (infection, rejection, dislocation, fracture of the implant) in the first 24 months after implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Males or females age 18 years or over at the time of inclusion into the study
- •Received a Synthes PSI® made of PEEK intended for replacement of bony voids in the cranial/craniofacial skeleton at least 24 months before inclusion in the study
- •Ability to obtain written informed consent from the recipient or the recipient's legal guardian
- •Ability to comply with the procedures described in the protocol, including responding to simple questionnaires either by the recipient in person or by a next relative (spouse, parent) who lives with the recipient
排除标准
- •Patient was contraindicated to receive a PSI made of PEEK at the time of implantation
结局指标
主要结局
Device related adverse events
时间窗: 0-24 months post initial implantation
Percentage of patients with the following device related adverse events: * infection * rejection * dislocation * fracture
次要结局
- Explantation(0 months - study visit at least 24 months after implantation (or scheduled up to 3 months after the study visit))
- Cosmetic result(At the study visit, which is at least 24 months after implantation)
- Clinical result(At the study visit, which is at least 24 months after implantation)
- Pressure sensitivity(At the study visit, which is at least 24 months after implantation)
- Heat / cold sensitivity(At the study visit, which is at least 24 months after implantation)
- Event-free survival(0 months - at the study visit, which is at least 24 months after implantation)
研究者
研究点 (30)
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