MMG vs. EMG for Cortical Breach Detection

Purpose

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.

Condition

  • Low Back Disorder

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intraoperative MMG vs EMG for cortical breach detection 		Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery.
  • Device: Triggered Electromyography
    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.
  • Device: Mechanomyography
    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

Recruiting Locations

More Details

NCT ID
NCT05352048
Status
Completed
Sponsor
Francis Farhadi