NCT05352048

MMG vs. EMG for Cortical Breach Detection

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Francis Farhadi · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Low Back Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-02
• Primary completion: 2024-07-09
• Completion: 2024-11-06
• First posted: 2022-04-28
• Last updated: 2025-08-19
• Results posted: 2025-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study