Post-Market Clinical Follow-up Study of A-SPINE's Products
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale- Change from baseline at 2 year
研究概览
简要总结
This is a post-market clinical follow-up study that use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to compare the clinical improvement effects before and after surgery.
详细描述
The purpose of study is to confirm the safety and and performance of the A-SPINE's products for using 2 years. This post-market clinical follow-up study use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to evaluate the clinical improvement effects. Subjects will be evaluated at pre-operation, 6 months, 12 months, and 2 years post treatment. Finally, analyze the clinical outcome, fusion rate, and adverse events.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is above 20 years of age;
- •Subject is indicated for A-SPINE Spinal Fixation System;
- •Subject is willing and able to provide informed consent to participate in the study;
- •Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits.
排除标准
- •Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion Criteria.
结局指标
主要结局
Visual Analogue Scale- Change from baseline at 2 year
时间窗: Change from baseline at 2 year
Visual Analogue Scale is a patient-reported outcome measure. The scale ranges from 0 to 10. A score of 0 represents no pain, while a score of 10 represents extreme pain. Compare baseline and postoperative improvement VAS scores.
次要结局
- Number of Device-related Adverse Events(Baseline, 6 months,12 months, 24 months)
- Oswestry Disability Index(Baseline, 6 months,12 months, 24 months)
- Fusion Rate(Baseline, 6 months,12 months, 24 months)
- Neck Disability Index(Baseline, 6 months, 12 months, 24 months)