DRKS00028811暂停不适用
on-interventional PMCF-study: a retrospective data collection and evaluation of clinical outcomes after vertebral body replacement with SAMSON®
HumanTech Spine GmbH0 个研究点目标入组 34 人开始时间: 2022年4月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 34
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
- •1. Patients who had clinical and radiological evidence of tumorous, inflammatory and traumatic diseases and injuries of the thoracic and lumbar spine, which led to instabilities in the area of the anterior column or compression of the neural structures, or for diseases requiring remediation as a result of inflammation.
- •2. Or have had clinical and radiological evidence of other diseases and injuries due to which the use of the SAMSON® Vertebral Body Replacement System was recommended by the attending surgeon.
- •3. Patients who have been treated using the SAMSON® Vertebral Body Replacement System between 01.05.2018 and 01.08.2021
- •4. Patients who have been at least 18 years old and skeletally matured at the time of surgery
- •5. Patients who are willing and able to provide a signed and dated informed consent, comply with the study plan
排除标准
- •1. Have any condition that would interfere with the subject’s ability to comply with study instructions or might confound the study interpretation.
- •2. Have had/ have any absolute contraindications listed in the instructions for use (IFU)
研究者
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