跳至主要内容
临床试验/NCT02272140
NCT02272140已完成不适用

A Prospective, Non-randomized, Multicenter Evaluation of the Utility of Transcutaneous Stimulation of the Lumbosacral Nerve Roots During XLIF® and Its Relationship to Postoperative Nerve Health

NuVasive12 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2014年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
324
试验地点
12
主要终点
Sensitivity and specificity of this neuromonitoring technique in identifying neural injury after the XLIF procedure.

研究概览

简要总结

The objective of this study is to evaluate the utility of localized stimulation of the lumbosacral nerve roots during XLIF through correlation of observed changes in the response latency, amplitude, waveform morphology, and/or response threshold with surgical events. Additionally, correlation between neuromonitoring findings and postoperative neural status will be evaluated.

详细描述

The utility of NVM5 neuromonitoring by stimulating within the surgical site during XLIF has been previously demonstrated; however, it is possible that depending on the site of injury, this method of monitoring may stimulate nerves at a location that is distal to the site of injury along the nerve conduction pathway. In this example, the site of injury would not disrupt the stimulus and a normal muscle response may occur, providing a false negative result. With this in mind, it has been hypothesized that more accurate information may be gathered by stimulating the lumbar roots or spinal nerves cranial to the surgical site and recording the subsequent muscle response in the lower limbs. Using this technique, the response to the stimulus would traverse the surgical site, including the site of any nerve injury. Currently, the only described method of stimulating cranial to the surgical site is with transcranial motor evoked potentials (tcMEP); stimulating the lumbosacral nerve roots locally has not been demonstrated. Though tcMEP monitoring is a well-documented technique, there are several limitations associated with its use. For example, tcMEP requires adherence to total intravenous anesthesia (TIVA), thereby restricting the use of inhalational agents. This restriction may require additional training and coordination with the anesthesiologist, as well as added cost to the hospital.6 Additional challenges with tcMEP include the requirements for high voltage stimulation to successfully transmit a stimulus across the skull. In rare instances this can cause seizures, tongue lacerations, and other complications. Finally, due to inclusion of the central nervous system, monitoring with tcMEP may be less reproducible and specific than a more localized stimulation.

To address these challenges, recent adaptations to standard MEP and EMG monitoring protocols have used local stimulation of the lumbosacral nerve roots at the level of the conus, with recorded responses from the relevant innervated muscle groups of the lower limbs. Early experience using this technique has shown the feasibility and reproducibility of obtaining reliable baseline and longitudinal responses throughout a surgical procedure, and incorporation of this monitoring modality has become common practice at certain surgical sites performing XLIF, although determination of clinically meaningful changes in those responses have yet to be determined.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female spine surgery patients who are at least 18 years of age;
  • Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless surgical treatment is clinically indicated earlier;
  • Surgical candidates for extreme lateral approach lumbar spine surgery at spinal levels L2 to L5, inclusive of L4-5;
  • Able to undergo surgery based on physical exam, medical history and surgeon judgment;
  • Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation.

排除标准

  • Patient has a mental or physical condition that would limit the ability to comply with study requirements;
  • Currently undergoing any surgical treatment at any spinal level other than L2 to L5;
  • Currently undergoing surgical treatment for significant deformity correction (e.g., osteotomy, anterior longitudinal ligament release, or other significant manipulation of the spinal column);
  • Underlying neurological disease or neurological deficit that is not associated with the condition for which he/she is seeking surgical intervention (e.g., diabetic peripheral neuropathy);
  • Implanted pacemaker, defibrillator, or other electronic devices;
  • Involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested);
  • Pregnant women;
  • Patient is a prisoner;
  • Patient is participating in another clinical study that would confound study data.

结局指标

主要结局

Sensitivity and specificity of this neuromonitoring technique in identifying neural injury after the XLIF procedure.

时间窗: 6 weeks

Intraoperative neuromonitoring findings will be correlated with postoperative neural status up to six weeks post-op to determine the sensitivity and specificity of this testing modality's ability to detect postoperative decreases in motor function during the XLIF procedure.

次要结局

未报告次要终点

研究者

发起方
NuVasive
申办方类型
Industry
责任方
Sponsor

研究点 (12)

Loading locations...

相似试验