MMG vs. EMG for Cortical Breach Detection

Study Overview
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Brief Summary
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The purpose of this study is to determine how well mechanomyography (MMG) and electromyography (EMG) prevent cortical bone breaches, or the pinching of a nerve from screw placement, in patients having lower back surgery requiring hardware. Both MMG and EMG are devices approved by the FDA to detect the location of nerves during surgery so they can be avoided. The results from both tests will be compared to one another to determine if one is better at accurately locating nerves than the other.

Official Title
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Prospective Evaluation of Mechanomyography Versus Triggered Electromyography for Intraoperative Assessment of Cortical Breaches During Instrumented Lumbar Spine Surgery

Conditions
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Low Back Disorder

Intervention / Treatment
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* Device: Triggered Electromyography
* Device: Mechanomyography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled to undergo a one-, two-, or three-level posterolateral spinal fusion surgery using Depuy Synthes Expedium pedicle screw instrumentation. over the age of 18 years old unresponsive to conservative care for a minimum of 6 months psychosocially, mentally, and physically able to fully consent and comply with this protocol Exclusion Criteria: preexisting medical condition or comorbidity that makes them a poor candidate open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis requires medications that may interfere with bone or soft tissue healing active local or systemic infection metal sensitivity/foreign body sensitivity implanted pacemaker morbidly obese, defined as a body mass index (BMI) greater than 45 osteoporosis involved in or planning to engage in litigation or receiving Workers Compensation related to neck or back pain.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoperative MMG vs EMG for cortical breach detection<br>Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery. | Device: Triggered Electromyography<br>* Triggered electromyography will be used during surgery to detect nerve impingement by pedicle screws used for spinal fusion. Threshold stimulation data from the device will be recorded.<br>Device: Mechanomyography<br>* SENTIO MMG ball tip probe will be used during surgery to detect nerve impingement by pedicle screws used for spinal fusion. Threshold stimulation data from the device will be recorded, and the accuracy compared to the data from the triggered electromyography.<br>* Other names: SENTIO MMG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of Pedicle Screw Trajectories | Patients with successful pedicle screw trajectories determined by the percentage of patients with A/B or C/D/E breaches. Grade A - No cortical breach (0 mm) Grade B - Pedicle cortical breach < 2 mm Grade C - Pedicle cortical breach = 2 to < 4 mm Grade D - Pedicle cortical breach = 4 to < 6 mm Grade E - Pedicle cortical breach = 6 mm | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Numeric Rating Scale (NRS) Questionnaire for pain. | This survey is used to assess pain experienced by the subject and the severity of the pain. Types of pain include numbness, pins and needles, dull aching, burning sensation, muscle cramps, and stabbing pain. Pain severity is rated on a scale of 0-10 where 0 is no pain and 10 is the worst pain imaginable. Pain is assessed in the neck, back, arms, and legs. | 6 weeks and 3 months after surgery | 
| Change in the Oswestry Disability Index version 2.1A | This survey is used to quantify disability for low back pain. There are five disability categories ranging from minimally disabled to crippled. The appropriate disability category is determined by the sum of the subjects points divided by the total possible points(50) times 100. This yields a % disabled score and this % determines the appropriate category designation. 0% is equated with no disability and 100% is the maximum disability possible. | 6 weeks and 3 months after surgery | 
| Change in the PROMIS Global-10 | This questionnaire is a 10 item patient reported tool used to quantify the patients general healthcare related quality of life. It assesses both physical and mental health and is scored as a percentage. Scores closer to 100% report a better quality of life than those who score lower. | 6 weeks and 3 months after surgery | 
| Change in the Short-From (SF-36) Health Survey | This survey quantifies how a patient feels about their health, and how well they are able to do common activities. This survey has 9 domains that assess the patients functional ability. The domains are scored as percentages from 0%-100% with 0% being severely limited and 100% being no deficits. | 6 weeks and 3 months after surgery | 
| Hospital Readmission at 30 days | Percent of patients undergoing hospital readmission 30 days following the procedure. | 30 days | 
| Hospital Readmission at 90 days | Percent of patients undergoing hospital readmission 90 days following the procedure. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower back surgery, Lumbar fusion