MMG vs. EMG for Cortical Breach Detection

Francis Farhadi

Status: Completed

Conditions: Low Back Disorder

Treatments: Device: Mechanomyography; Device: Triggered Electromyography

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05352048

76122

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Intraoperative MMG vs EMG for cortical breach detection

Experimental group

Description:

Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery.

Treatment:

Device: Triggered Electromyography

Device: Mechanomyography