NCT05648474招募中不适用
Advanced Techniques in Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure: a Utility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of SSEP neuromonitoring in post-operative clinical diagnosis of motor/sensory deficits
研究概览
简要总结
This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk during the lateral lumbar interbody fusion (LLIF) procedure.
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
- •At least 18 years of age at the time of planned surgery.
- •Indicated for 1- or 2-level instrumented LLIF surgery (in either prone or lateral decubitus positions), inclusive of the L4-5 disc space.
- •Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
排除标准
- •Patients requiring surgical treatment at more than 2 lumbar levels.
- •Patients with peripheral neuropathy such as from diabetes or other conditions that might affect the reliability of intraoperative neuromonitoring.
- •Patients with prior history of partial/full hip or knee joint replacement surgery (i.e., arthroplasty or resurfacing) on the leg targeted for saphenous monitoring and electrode placement.
- •Patients with presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- •Female patients who are pregnant or wanting to become pregnant during the timeframe of study participation.
- •Patients participating in another clinical study which may compromise this study's results or compliance with this study's procedures.
结局指标
主要结局
Sensitivity and specificity of SSEP neuromonitoring in post-operative clinical diagnosis of motor/sensory deficits
时间窗: 6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months.
This outcome measure determines the utility of the saphenous nerve SSEP monitoring based on the correlation of intraoperative neuromonitoring results with new or worsened postoperative neural deficits, as measured by motor and sensory physical exam.
次要结局
- Determination of the positive predictive value (PPV) and negative predictive value (NPV) of free run and SSEP monitoring modalities.(6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months.)
研究者
研究点 (1)
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