DRKS00024355招募中不适用
A prospective observational study to evaluate the safety and performance of BonOs® Inject bone cement used in cement-augmented pedicle screw fixation
OSARTIS GmbH0 个研究点目标入组 90 人开始时间: 2021年6月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •All patients undergoing pedicle screw augmentation as indicated in the IFUs of the used screw system and BonOs® Inject.
- •-Male or female = 18 years on the day of screening
- •-Patient is willing to participate in the routine postoperative follow-up program
- •-Patient has signed written informed consent
排除标准
- •-Patients who do not meet the inclusion criteria and present any conditions contraindicated for BonOs® Inject or the used screw system
- •-Severe generalized disease resulting in a life expectancy shorter than 12 months
- •-Pregnant or breast-feeding women (urine pregnancy test)
- •-Women of childbearing potential without effective contraception
- •-Alcohol or drug abuse (clinical manifestation)
- •-Subjects with psychiatric disorders influencing their judgment or autonomy
- •-Inability or unwillingness to understand or comply with the required study procedures
- •-Subject who are not suitable for the study based on the principal investigator’s evaluation
研究者
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