Multicenter PMCF Study on the Safety and Performance of CESPACE 3D - A Prospective Study on Total Indications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Change of Neck Specific Disability measured by Neck Disability Index (NDI)
研究概览
简要总结
Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)
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
- •Patient is minimum 18 years old
- •Written informed consent for the documentation of clinical and radiological results
- •Patient's indication according to IFU
- •Patient is not pregnant
排除标准
- •Patient is not willing or able to participate at the follow-up examination
结局指标
主要结局
Change of Neck Specific Disability measured by Neck Disability Index (NDI)
时间窗: preoperative, 12 months postoperative
The NDI is designed to measure neck-specific disability. The questionnaire has 10 items to measure patient-reported disability secondary to neck pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation and patients rate their status from 0 (best) to 5 (worst imaginable). Individual item responses are summed to a total score, where 0 points indicate no activity limitations and 50 points indicate complete activity limitation.
次要结局
- JOA score(preoperatively and at one follow-up- assessment after a minimum of one year postoperatively)
- Pain (VAS)(preoperatively and at one follow-up- assessment after a minimum of one year postoperatively)
- development of EQ-5D-5L(preoperatively and at one follow-up- assessment after a minimum of one year postoperatively)
- development of radiological outcome(preoperatively and at one follow-up- assessment after a minimum of one year postoperatively)
- Rate of AE/SAEs(preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively)
- Patient Satisfaction with Treatment Outcome(at one follow-up- assessment after a minimum of one year postoperatively)