MMG vs. EMG for Cortical Breach Detection

NCT05352048 | Completed Results FDA Device

• 1 other identifier: 76122
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Keywords

Lower back surgery; Lumbar fusion

Outcome Measures

Primary Outcomes (1)

• Success of Pedicle Screw Trajectories

  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

  1 hour

Secondary Outcomes (6)

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

  3 months after surgery

• Change From Baseline in the Oswestry Disability Index Version 2.1A

  3 months after surgery

• Change From Baseline in the PROMIS Global-10

  3 months after surgery

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

  6 weeks and 3 months after surgery

• Hospital Readmission at 30 Days

  30 days

Study Arms (1)

Intraoperative MMG vs EMG for cortical breach detection

EXPERIMENTAL

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

Device: Triggered Electromyography; Device: Mechanomyography

Interventions

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.

Intraoperative MMG vs EMG for cortical breach detection

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.

Also known as: SENTIO MMG

Intraoperative MMG vs EMG for cortical breach detection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francis Farhadi: lead
• DePuy Synthes: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Results Point of Contact

• Title: Dr. Francis Farhadi
• Organization: University of Kentucky

francis.farhadi@uky.edu

859-323-5661

Study Officials

• H. Francis Farhadi, MD, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: August 2, 2022
• Primary Completion: July 9, 2024
• Study Completion: November 6, 2024
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)