Nerve Monitoring Devices for Spinal Fusion Surgery

Recruiting at 1 trial location

Overseen By Greg Ambra

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Retropsoas Technologies, LLC

Must not be taking: Chemotherapy, Radiation, Immunosuppressants

Disqualifiers: Lumbar trauma, Pregnancy, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness and safety of two nerve monitoring devices, including the Nerve Cuff and Retractor System, used during a type of back surgery called TLIF. These devices help surgeons monitor nerves and muscles to ensure proper function during the procedure. The trial will evaluate how well each device tracks the nervous system's response during surgery. Suitable candidates are those needing TLIF surgery on their lower back, excluding the L5-S1 level, and who do not have specific allergies or health issues like severe leg swelling. As an unphased trial, this study offers patients the chance to contribute to advancements in surgical technology and improve outcomes for future patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently undergoing treatment with chemotherapy, radiation, or immunosuppression, you would not be eligible to participate.

What prior data suggests that these nerve monitoring devices are safe for spinal fusion surgery?

Research has shown that the Nerve Cuff and Retractor System used in spinal fusion surgery is generally safe. Studies have found that transforaminal lumbar interbody fusion (TLIF), the type of surgery using these devices, is effective and well-tolerated by patients. TLIF outcomes are similar to those of other fusion methods. Reports indicate that this system helps protect muscle function around the spine and monitors nerves during surgery, resulting in rare side effects and generally positive patient experiences. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nerve Cuff and Retractor System for spinal fusion surgery because it could enhance precision and safety during the procedure. Unlike traditional nerve monitoring devices, this system uses advanced techniques to provide real-time feedback, potentially reducing the risk of nerve damage. This innovative approach could lead to better surgical outcomes and quicker recovery times for patients undergoing TLIF surgeries.

What evidence suggests that these nerve monitoring devices are effective for spinal fusion surgery?

Research has shown that nerve monitoring devices during spinal fusion surgery can enhance safety by tracking nerve function. In this trial, the Nerve Cuff and Retractor System will precisely monitor nerves, which is crucial during surgeries like TLIF (transforaminal lumbar interbody fusion). Studies have found TLIF to be effective and safe, leading to favorable surgical outcomes and quicker recovery times. The surgery's minimally invasive nature results in less blood loss and shorter hospital stays. The Nerve Cuff and Retractor System aims to enhance these benefits by ensuring careful nerve monitoring throughout the procedure. ^{1 2 6 7 8}

Who Is on the Research Team?

Nicholas Poulos, MD

Principal Investigator

Retropsoas Technologies, LLC

Are You a Good Fit for This Trial?

This trial is for individuals undergoing a single or two-level TLIF spinal fusion surgery between L2-S1. It's not suitable for those with more than two levels of lumbar interbody fusion needed, only L5-S1 level surgery, acute trauma, previous relevant surgeries, BMI over 40, smokers, certain muscle weakness or vascular diseases, allergies to anesthesia or materials used in the cuff and retractor system.

Inclusion Criteria

I am having a spine surgery between the lower back and tailbone.

Exclusion Criteria

I need surgery only at the base of my spine.

BMI > 40 kg/m2

I need immediate treatment for a recent severe lower back injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo TLIF surgery with monitoring using the EARP Nerve Cuff Electrode and Retractor system

During surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

6 weeks

1 visit (in-person) at 6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nerve Cuff and Retractor System

Trial Overview The study tests the effectiveness and safety of the EARP Nerve Cuff Electrode and Retractor compared to standard nerve monitoring tools during TLIF surgery. The goal is to see which method better monitors nervous system activity safely during the operation.

How Is the Trial Designed?

Group I: Undergoing a single-level or two-level TLIF between L2-S1 Experimental Treatment 1 Intervention

During the surgery, the standard monitoring devices and the EARP monitoring study devices and techniques will be used.

Who Is Running the Clinical Trial?

Retropsoas Technologies, LLC

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

Monitoring saphenous somatosensory-evoked potentials (saphSSEP) during prone lateral interbody fusion (LIF) surgeries provided reliable and predictive information about femoral nerve health, with actionable feedback that allowed for intraoperative interventions.

In cases where saphSSEP changes were detected, most patients (24 out of 31) showed recovery of nerve function during surgery, indicating that saphSSEP monitoring can help prevent postoperative nerve deficits, although some patients experienced transient issues that resolved over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saphenous somatosensory-evoked potentials monitoring of femoral nerve health during prone transpsoas lateral lumbar interbody fusion. Tohmeh, A., Somers, C., Howell, K.[2022]

The cuff electrode described is a simple and cost-effective device made from common materials, allowing for extracellular nerve stimulation and recording without the need for specialized equipment.

Its design includes a silicone rubber holder that keeps the nerve in place and prevents drying during recordings, enhancing the reliability of nerve signal measurements in experimental settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple electrode for intact nerve stimulation and/or recording in semi-chronic rats. Sauter, JF., Berthoud, HR., Jeanrenaud, B.[2019]

The new sensing device for monitoring the recurrent laryngeal nerve during thyroid surgery is designed to be atraumatic and easy to use, enhancing safety by detecting imminent nerve trauma.

This device operates outside the sterile field and provides continuous monitoring throughout the surgery, which could improve surgical outcomes by allowing real-time nerve protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Continuous monitoring of the recurrent laryngeal nerve]. Lamadé, W., Brandner, R., Brauer, M., et al.[2011]

The modified cylindrical nerve cuff electrode can be fabricated with high precision (contact placement of 0.51 ± 0.04 mm) using minimal CAD and CAM skills, making it accessible for consistent production.

This design allows for selective recording and stimulation by optimizing contact placement and maintaining flexibility, with a 25% expansion observed under pressure, indicating its adaptability to nerve swelling post-implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fabrication of High Contact-Density, Flat-Interface Nerve Electrodes for Recording and Stimulation Applications. Dweiri, YM., Stone, MA., Tyler, DJ., et al.[2018]

A new continuous monitoring device for the recurrent laryngeal nerve (RLN) during thyroid surgery was tested in a phase-one clinical trial with 55 patients, showing no permanent nerve injuries.

The device allows for atraumatic, easy-to-use, and sensitive monitoring of the RLN, providing real-time audio feedback to surgeons and detecting even reversible nerve irritation, enhancing patient safety during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[First continuous nerve monitoring in thyroid gland surgery]. Lamadé, W., Meyding-Lamadé, U., Buchhold, C., et al.[2019]

A new device for intraoperative monitoring of the recurrent laryngeal nerve (RLN) was tested in piglets and proved to be reliable and user-friendly.

This monitoring system can detect imminent injury to the RLN during thyroid surgery, potentially reducing the significant morbidity associated with RLN damage, which can affect up to 20% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intraoperative monitoring of the recurrent laryngeal nerve. A new method]. Lamade, W., Fogel, W., Rieke, K., et al.[2011]

The novel cuff electrode design features a closed cavity that allows for the circulation of cooled liquid, enabling precise temperature control for reversible nerve conduction blocking.

This device not only facilitates monitoring of nerve conduction at different temperatures but also allows for reversible blocking using chemical agents, enhancing its versatility in nerve studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new cuff electrode for reversible conduction blocking. Brunner, M., Koch, UT.[2019]

A new surgical navigation system was developed that provides real-time auditory and visual feedback to help surgeons avoid damaging the facial nerve during drilling, achieving submillimeter accuracy in target registration.

In phantom experiments, the navigation system significantly reduced the error in maintaining a safe margin from the facial nerve compared to traditional methods, and its clinical feasibility was confirmed in three real surgeries, suggesting it could enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Warning navigation system using real-time safe region monitoring for otologic surgery. Cho, B., Oka, M., Matsumoto, N., et al.[2022]

In a study of 100 consecutive lateral lumbar interbody fusion surgeries, the use of distal Saphenous nerve Somatosensory Evoked Potentials (DSn-SSEPs) was found to be a valuable method for continuously monitoring the integrity of the femoral nerve, helping to prevent nerve injuries during surgery.

The DSn-SSEPs provided reliable monitoring despite challenges like muscle artifacts and patient movement, making it a recommended adjunct to standard neuromonitoring techniques in these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distal Stimulation Site at the Medial Tibia for Saphenous Nerve Somatosensory Evoked Potentials (DSn-SSEPs) in Lateral Lumbar Spine Procedures. Overzet, K., Mora, D., Faust, E., et al.[2022]

In a study of 354 spinal deformity surgeries, multimodal intraoperative neuromonitoring (using SSEPs and MEPs) achieved a 100% sensitivity and 99.3% specificity in detecting potential spinal cord injuries, significantly reducing the risk of permanent neurological deficits to just 1.6%.

The study emphasizes the importance of continuous communication among surgical teams to optimize the use of multimodal monitoring, which is now considered the gold standard for ensuring patient safety during complex spinal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of multimodal spinal cord monitoring in scoliosis surgery: a single centre experience of 354 operations. Bhagat, S., Durst, A., Grover, H., et al.[2019]

The newly designed nerve monitor allows for safe and reliable monitoring of various nerves during microneurosurgical procedures, including the facial nerve and spinal nerves, enhancing surgical precision.

This portable system, weighing only 1.8 kg, enables continuous monitoring without interrupting surgery, providing both quantitative and qualitative feedback through a display and auditory signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A newly designed nerve monitor for microneurosurgery: bipolar constant current nerve stimulator and movement detector with a pressure sensor. Shibuya, M., Mutsuga, N., Suzuki, Y., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7218951/

Clinical outcomes of minimally invasive transforaminal ... Objective. To assess the feasibility and clinical results of microscopic minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25527402/

Effectiveness and safety of transforaminal lumbar interbody ... The current study confirmed that TLIF approach in patients with previous laminectomy is effective and safe with good outcomes.

3. journals.lww.com journals.lww.com/10.1097/BSD.0000000000001181

Perioperative Modifications to the Open TLIF Provide... The results of this study identify that patients who underwent modified Open TLIF demonstrated favorable short-term outcomes, as compared with the tubular MIS- ...

4. fortunejournals.com fortunejournals.com/articles/longterm-functional-and-radiological-outcome-of-minimally-invasive-transforaminal-lumbar-interbody-fusion-mis-tlif-in-lumbar-degen.html

A Retrospective Study in 110 Patients MIS TLIF demonstrates efficacy as a surgical intervention for lumbar degenerative diseases, delivering positive long-term functional and radiological outcomes.

5. researchgate.net researchgate.net/publication/7181212_Minimally_invasive_transforaminal_lumbar_interbody_fusion_Indications_technique_and_complications

Minimally invasive transforaminal lumbar interbody fusion It has various advantages such as less invasiveness, lower intraoperative blood loss, and short hospital stay [3]. This surgery has become the ...

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/0300060520920090

Clinical outcomes of minimally invasive transforaminal ... MIS-TLIF can be performed safely and effectively using this tapered tubular retractor system, which helps preserve the multifidus. Introduction.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3489237/

Transforaminal lumbar interbody fusion: a safe technique with ... The TLIF technique has comparable results to other interbody fusions, such as the PLIF and ALIF techniques.

8. jss.amegroups.org jss.amegroups.org/article/view/3512/html

Lumbar interbody fusion: techniques, indications and ... Lumbar interbody fusion: techniques, indications and comparison of interbody fusion options including PLIF, TLIF, MI-TLIF, OLIF/ATP, LLIF and ALIF.