A Prospective Evaluation of the Dynamic Function of the NeuroVision® System for the Placement of Lumbar Pedicle Screws
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Sensitivities/specificities of NeuroVision Basic and Dynamic Screw Test monitoring modalities to predict (1) pedicle breach and (2) neural injury
研究概览
简要总结
The purpose of this research study is to gather information about the NeuroVision System (which is FDA cleared for this indication) during the placement of pedicle screws. NeuroVision is a machine that monitors nerve activity during surgery and will alert the surgeon if there are any nerve-related issues during screw placement. The use of nerve monitoring is standard of care at most centers during spine surgery. The standard monitoring for screws placed is performed after the screw is placed, to ensure it is well positioned in the bone (if it is not, the screw may be removed and/or repositioned). The NeuroVision System has a novel feature called "Dynamic Screw Test" that allows for that monitoring to be performed as the screw is placed, rather than after the fact. This study is being done to determine if this real-time monitoring of screw placement provides beneficial additional information to the operating surgeon to prevent misplacement of screws before it happens.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Male and female patients who are at least 18 years of age.
- •Surgical candidates for posterior instrumented lumbar fusion surgery.
- •Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study.
排除标准
- •Patients with underlying neurological disease or neurological deficits that are not associated with the condition for which they are seeking surgical intervention.
- •Patients who have had previous instrumented surgery at the involved lumbar level.
- •Participants in any other clinical study involving an investigational device or drug within 30 days of enrollment into the current study.
结局指标
主要结局
Sensitivities/specificities of NeuroVision Basic and Dynamic Screw Test monitoring modalities to predict (1) pedicle breach and (2) neural injury
时间窗: 6 weeks postoperative
次要结局
- Intraoperative time (in minutes) taken to place Basic vs Dynamically tested screws.(Intraoperative)
- Intraoperative fluoroscopy (in minutes) used to place Basic vs Dynamically tested screws.(Intraoperative)
- The change in subject self-reported pain ratings (Visual Analog Scales, leg and back pain) from the preoperative period through postoperative follow-up.(6 weeks postoperative)