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Completed

NCT Number: NCT05352048

MMG vs. EMG for Cortical Breach Detection

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.

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Key information

Conditions

Low Back Disorder

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triggered Electromyography

Device

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.

Mechanomyography

Device

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.

Other names: SENTIO MMG

Primary outcomes

  1. Success of Pedicle Screw Trajectories

    Time frame: 1 hour

    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

Secondary outcomes

  1. Change From Baseline in the Numeric Rating Scale (NRS) Questionnaire for Pain.

    Time frame: 3 months after surgery

    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].

  2. Change From Baseline in the Oswestry Disability Index Version 2.1A

    Time frame: 3 months after surgery

    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]

  3. Change From Baseline in the PROMIS Global-10

    Time frame: 3 months after surgery

    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]

  4. Change in the Short-From (SF-36) Health Survey

    Time frame: 6 weeks and 3 months after surgery

    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.

  5. Hospital Readmission at 30 Days

    Time frame: 30 days

    Percent of patients undergoing hospital readmission 30 days following the procedure.

  6. Hospital Readmission at 90 Days

    Time frame: 90 days

    Percent of patients undergoing hospital readmission 90 days following the procedure.

Sponsors and collaborators

Lead sponsor

Francis Farhadi

Other

Collaborators

  • DePuy Synthes

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2022
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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