Evaluation Of A Novel Technique To Monitor Neurophysiological Activity During TLIF Surgery Using The Endoscopic Assisted Retropsoas (EARP) Nerve Cuff Electrode and Retractor With A Commercially Available Lumbar Spine Retractor System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Ability of EARP System to alert the surgeon to nerve irritation during surgery compared to standard IONM monitoring techniques
研究概览
简要总结
The purpose of this study is to evaluate the differences (the effectiveness and the safety) between two different nerve and muscle monitoring devices currently available during a TLIF surgery.
The Endoscopic Assisted Retropsoas (EARP) Nerve Cuff Electrode and Retractor surgical and nerve monitoring tools will be used in addition to standard nerve monitoring tools during the surgery. The choice of standard nerve monitoring equipment is based on the decision of the surgeon and technologist and is not dictated by this study.
These tools will be compared with regards to safety and ability to accurately monitor the nervous system during the surgery.
详细描述
The application of traditional SSEPs and tcMEPs to lumbar nerve root monitoring during TLIF surgery is both challenging and problematic. When applied to lumbar nerve root monitoring, SSEPs and tcMEPs unfortunately suffer in specificity, sensitivity, or both. A surgeon thus cannot confidently rely on these techniques to monitor nerve root function and must guess the likelihood of dysfunction.
Spontaneous EMG (sEMG) is also used to monitor nerve root activity. While sEMG is an excellent indicator of spinal nerve root manipulation, it is a poor diagnostic indicator of dysfunction. 90-95% of sEMG alerts are not associated with dysfunction yielding a high false positive rate and poor specificity, and postoperative deficits are often not associated with sEMG alerts yielding many false negatives and poor sensitivity. The primary utility of sEMG is to use as an indicator of manipulation, which prompts the acquisition of tcMEPs to assess function.
There is a clear need to take the guesswork out of monitoring the functional status of nerve roots at risk during lumbar decompressions and select interbody fusions. During TLIFs, the exiting nerve root is at risk as it courses obliquely across disc space encroaching on the surgical corridor. Standardly, a hand-held retractor is used to retract and protect the nerve root during disc space preparation, implant insertion or even simple decompression. This maneuver and retraction place a particular nerve root at risk, but again, traditional SSEP and tcMEPs are not ideal for monitoring that risk.
The EARP Nerve Cuff Electrode (Retropsoas Technologies) is a novel, Class II, device that is 510(k) cleared by FDA. It conducts electrical signals as a component of intraoperative neuromonitoring, is used with commercially available neuromonitoring systems, and does not stimulate or record the signal itself. The standard connectors at the proximal end interface with the neuromonitoring equipment. The distal nerve cuff electrode partially encircles and contacts the target nerve root. It uses a bipolar configuration to limit current spread. It is available in several inner diameters to accommodate variability in patient nerve root size anatomy.
The EARP Retractor is a Class I device used with a commercially available Retractor system and is only used as an additional 4th blade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing TLIF between L2-S1
排除标准
- •Requiring TLIF surgery only at the L5-S1 level
- •Acute lumbar spine trauma requiring immediate intervention
- •Allergy or contraindication to propofol
- •Lower extremity amputation
- •Significant lower extremity edema noted on clinical exam
- •Current treatment with chemotherapy, radiation, or immunosuppression
- •Pregnant, or plans on becoming pregnant in the near future
- •History of allergy to titanium, platinum, aluminum, stainless steel, or silicon
研究组 & 干预措施
Undergoing a single-level or two-level TLIF between L2-S1
During the surgery, the standard monitoring devices and the EARP monitoring study devices and techniques will be used.
干预措施: Nerve Cuff and Retractor System (Device)
结局指标
主要结局
Ability of EARP System to alert the surgeon to nerve irritation during surgery compared to standard IONM monitoring techniques
时间窗: During the TLIF surgery.
Signal amplitude at baseline, during initial retraction, and maintenance of retraction will be analyzed for changes using a 50% decrease as a surgeon alert. IONM assessments using traditional electrodes: SSEPs, tcMEPs and tfMEP. IONM assessments using EARP cuff: cuff SSEPs, cuff tcMEPs, and cuff tfMEPs.
Number of patients that experience an Adverse Device Effect (ADE)
时间窗: From enrollment through the end of the follow-up assessment at week 6
Adverse device effect (ADE) - Adverse event (AE) judged by the clinician related to the use of an investigational devices. This includes any AE resulting from insufficient or inadequate instructions for use or the deployment, implantation, installation, or operation, or any malfunctioning of the investigational devices and any event resulting from use error or from unintentional misuse of the investigational devices.
次要结局
- Assess monitorability of muscles/nerves(During the TLIF surgery.)
- Evaluate the specificity and sensitivity of alerts to neurological deficits.(From time of surgery through the end of the follow-up assessment at week 6)
- Assess the change from baseline to end of surgery for each muscle and modality(From enrollment through the end of the follow-up assessment at week 6)