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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Nerve Cuff and Retractor System for spinal fusion surgery?

The research on nerve monitoring devices, such as the newly designed nerve monitor and the cuff electrode for reversible conduction blocking, suggests that these technologies can safely and reliably monitor nerve health during surgery. This implies that similar devices, like the Nerve Cuff and Retractor System, may also be effective in ensuring nerve safety during spinal fusion surgery. ^{1 2 3 4 5}

Is the Nerve Monitoring Device for Spinal Fusion Surgery safe for humans?

Research on similar nerve monitoring devices, like nerve cuff electrodes, shows they are designed to be safe, robust, and reliable for long-term use. These devices have been tested in animals and are made to be flexible and stable, suggesting they are generally safe for human use. ^{1 6 7 8 9}

How is the Nerve Cuff and Retractor System treatment for spinal fusion surgery different from other treatments?

The Nerve Cuff and Retractor System is unique because it combines nerve monitoring with a retractor system, allowing for continuous and real-time monitoring of nerve activity during spinal fusion surgery. This helps prevent nerve damage by providing immediate feedback to the surgeon, which is not typically available with standard surgical tools. ^{3 7 8 10 11}

Research Team

Nicholas Poulos, MD

Principal Investigator

Retropsoas Technologies, LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Saphenous somatosensory-evoked potentials monitoring of femoral nerve health during prone transpsoas lateral lumbar interbody fusion. [2022]

2. United States 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. [2022]

3. Austria pubmed.ncbi.nlm.nih.gov

A newly designed nerve monitor for microneurosurgery: bipolar constant current nerve stimulator and movement detector with a pressure sensor. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

An evaluation of multimodal spinal cord monitoring in scoliosis surgery: a single centre experience of 354 operations. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A new cuff electrode for reversible conduction blocking. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Fabrication of High Contact-Density, Flat-Interface Nerve Electrodes for Recording and Stimulation Applications. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

A simple electrode for intact nerve stimulation and/or recording in semi-chronic rats. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[Continuous monitoring of the recurrent laryngeal nerve]. [2011]

9. Germany pubmed.ncbi.nlm.nih.gov

[Intraoperative monitoring of the recurrent laryngeal nerve. A new method]. [2011]

10. Germany pubmed.ncbi.nlm.nih.gov

Warning navigation system using real-time safe region monitoring for otologic surgery. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

[First continuous nerve monitoring in thyroid gland surgery]. [2019]