Prospective Robotic Global Research Study (PROGRESS)
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale
研究概览
简要总结
The purpose of this study is to prospectively review outcomes of patients who have surgery with the ExcelsiusGPS™ robotics system in order to analyze screw placement accuracy. Patient demographics, intraoperative data and radiographic imaging to determine screw placement accuracy will be collected and reviewed. This information will be compared in a separate study to retrospectively collected data from sites who have done a similar number of cases without the robot.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age and a maximum age of 85 years
- •Require surgery that includes posterior stabilization with screws to be inserted in cervical, thoracic, lumbar spine or sacrum
- •Able to sign Informed Consent
排除标准
- •Previous fusion or fusion attempt at index level(s)
- •DEXA score of -2.5 or below (only if clinically indicated - optional)
- •Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
- •History of substance abuse (drugs or alcohol)
- •Mentally incompetent or prisoner
- •Worker's compensation
- •Pregnant or intention to become pregnant
结局指标
主要结局
Numeric Rating Scale
时间窗: 24 months
Pain rating scale
SF-12
时间窗: 24 months
12-Item short form health survey
Oswestry Disability Index
时间窗: 24 months
Index derived from the Oswestry Low Back Pain Questionnaire
Screw Placement Accuracy
时间窗: 2 weeks
Gertzbein Robbins Scale for screw accuracy
Complications
时间窗: through study completion, 2 years
Adverse Event
次要结局
未报告次要终点