MMG vs EMG for Cortical Breach Detection in Low Back Pain

Overseen By H. Francis Farhadi, MD. PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Francis Farhadi

Must not be taking: Bone healing drugs

Disqualifiers: Osteoporosis, Infection, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

65 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Francis Farhadi, MD, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for adults over 18 who need lower back surgery with Expedium pedicle screw instrumentation, have not improved after 6 months of non-surgical care, and can fully participate in the study. It's not for those with open wounds near the surgery site, severe obesity (BMI >45), ongoing legal cases or Workers Compensation for neck/back pain, medications affecting healing, osteoporosis, infections, metal sensitivity/pacemakers, or other serious health issues.

Inclusion Criteria

I am over 18 years old.

My condition hasn't improved after 6 months of standard treatment.

I am scheduled for a spinal fusion surgery using specific Depuy Synthes screws.

Exclusion Criteria

Metal sensitivity/foreign body sensitivity

Implanted pacemaker

Involved in or planning to engage in litigation or receiving Workers Compensation related to neck or back pain

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intraoperative Assessment

Participants undergo lower spine fusion surgery with MMG and EMG assessments for cortical breach detection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessments of pain, disability, and quality of life

3 months

Multiple visits (in-person and virtual) at 6 weeks, 3 months

Treatment Details

Interventions

• Mechanomyography
• Triggered Electromyography

Trial Overview The study compares mechanomyography (MMG) and electromyography (EMG), both FDA-approved nerve detection devices used during lower back surgeries to prevent nerve damage from screw placement. The goal is to see which method is more accurate at locating nerves to avoid cortical bone breaches.

Participant Groups

Group I: Intraoperative MMG vs EMG for cortical breach detection Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Francis Farhadi

Lead Sponsor

Trials

2

Recruited

330+

H. Francis Farhadi

Lead Sponsor

Trials

4

Recruited

410+

DePuy Synthes

Industry Sponsor

Trials

33

Recruited

4,900+