MMG vs. EMG for Cortical Breach Detection

N/ACompletedNCT05352048

Francis Farhadi65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Low Back Disorder

Interventions

Triggered ElectromyographyDEVICE

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.

MechanomyographyDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Kentucky

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

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

Time frame: 1 hour

Secondary Outcomes

Change From Baseline 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 back and legs. Changes reported as percentages using the formula \[(Average measure at 3 months - Average measure at baseline)/Average measure at baseline\].

Time frame: 3 months after surgery

Change From Baseline 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. Changes reported as percentages using the formula \[(Average measure at 3 months - Average measure at baseline)/Average measure at baseline\]

Time frame: 3 months after surgery

Change From Baseline 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. Changes reported as percentages using the formula \[(Average measure at 3 months - Average measure at baseline)/Average measure at baseline\]

Data from ClinicalTrials.gov

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