Prospective Evaluation of Mechanomyography Versus Triggered Electromyography for Intraoperative Assessment of Cortical Breaches During Instrumented Lumbar Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Success of Pedicle Screw Trajectories
研究概览
简要总结
The purpose of this study is to determine how well mechanomyography (MMG) and electromyography (EMG) prevent cortical bone breaches, or the pinching of a nerve from screw placement, in patients having lower back surgery requiring hardware. Both MMG and EMG are devices approved by the FDA to detect the location of nerves during surgery so they can be avoided. The results from both tests will be compared to one another to determine if one is better at accurately locating nerves than the other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •scheduled to undergo a one-, two-, or three-level posterolateral spinal fusion surgery using Depuy Synthes Expedium pedicle screw instrumentation.
- •over the age of 18 years old
- •unresponsive to conservative care for a minimum of 6 months
- •psychosocially, mentally, and physically able to fully consent and comply with this protocol
排除标准
- •preexisting medical condition or comorbidity that makes them a poor candidate
- •open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis
- •requires medications that may interfere with bone or soft tissue healing
- •active local or systemic infection
- •metal sensitivity/foreign body sensitivity
- •implanted pacemaker
- •morbidly obese, defined as a body mass index (BMI) greater than 45
- •osteoporosis
- •involved in or planning to engage in litigation or receiving Workers Compensation related to neck or back pain.
结局指标
主要结局
Success of Pedicle Screw Trajectories
时间窗: 1 hour
Patients with successful pedicle screw trajectories determined by the percentage of patients with A/B or C/D/E breaches. * Grade A - No cortical breach (0 mm) * Grade B - Pedicle cortical breach \< 2 mm * Grade C - Pedicle cortical breach = 2 to \< 4 mm * Grade D - Pedicle cortical breach = 4 to \< 6 mm * Grade E - Pedicle cortical breach = 6 mm
次要结局
- Change in the Short-From (SF-36) Health Survey(6 weeks and 3 months after surgery)
- Change From Baseline in the Numeric Rating Scale (NRS) Questionnaire for Pain.(3 months after surgery)
- Change From Baseline in the Oswestry Disability Index Version 2.1A(3 months after surgery)
- Change From Baseline in the PROMIS Global-10(3 months after surgery)
- Change in the Short-From (SF-36) Health Survey(6 weeks and 3 months after surgery)
- Hospital Readmission at 30 Days(30 days)
- Hospital Readmission at 90 Days(90 days)
研究者
Francis Farhadi
Associate Professor
University of Kentucky