MMG vs. EMG for Cortical Breach Detection

NCT ID: NCT05352048

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2024-11-06

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Triggered Electromyography

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

SENTIO MMG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DePuy Synthes

INDUSTRY

Sponsor Role: collaborator

Francis Farhadi

OTHER

Sponsor Role: lead

Responsible Party

Francis Farhadi

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

H. Francis Farhadi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

76122

Identifier Type: -

Identifier Source: org_study_id