Total Indications Ennovate® Non-Interventional Study on Clinical and Radiological Results With Pedicle Screw Fixation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 188
- 试验地点
- 7
- 主要终点
- Change of Clinical Results from Preoperative Status to Follow-Up at 12 Months
研究概览
简要总结
This study is planned and conducted to document all patients in the participating Centers, who are treated with the CE-marked product, the Fixateur Ennovate®, regardless of the diagnosis or indication. Data on performance and safety of the product, validated patient based questionnaires (Oswestry Disability Index, ODI) as well as the satisfaction of the patients in general are captured.
详细描述
The list of spinal treatments is growing, and healthcare authorities today are at times limiting their access due to a lack of evidence of safety and efficiency.
The study enables a quick, but detailed implant documentation, which is of great interest for the current and future users of the internal fixation system targeted in this study. It includes the relevant outcomes to evaluate safety and efficacy of the implant system for various indications in trauma and degenerative disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Consent in the documentation of clinical and radiological results
排除标准
- •If it is clear that the patient cannot participate in a follow-up examination, he will be excluded from the study documentation.
结局指标
主要结局
Change of Clinical Results from Preoperative Status to Follow-Up at 12 Months
时间窗: preoperative, 12 months postoperative
Clinical Results measured by Oswestry Disability Index (ODI). ODI contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel, each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. Each question is scored on a scale of 0 (indicating the least amount of disability) to 5 5 (indicating most severe disability). The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
次要结局
未报告次要终点