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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two devices, Mechanomyography (MMG) and Triggered Electromyography (EMG), to determine which better prevents nerve pinching during lower back surgery. Both devices assist doctors in identifying nerves to avoid them when placing screws in the spine. Candidates for this trial include individuals scheduled for specific back surgeries who have not found relief from other treatments for at least six months. The goal is to determine which device more accurately locates nerves to improve surgical outcomes. As an unphased trial, this study allows patients to contribute to innovative research that could enhance surgical precision and outcomes.

What prior data suggests that these devices are safe for detecting nerve locations during surgery?

Research has shown that using mechanomyography (MMG) during surgeries is safe. One study found that MMG successfully prevented incorrect screw placement near nerves 99.5% of the time, demonstrating its reliability in avoiding nerve damage.

Triggered electromyography (EMG) is also considered safe. Studies have shown that EMG is 95.5% accurate in guiding screw placement in the spine, reducing the risk of pinching nerves during surgery.

Both MMG and EMG have FDA approval for detecting nerves during surgery, indicating they have passed safety checks for their intended use. No major safety issues have been reported with either method so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing Mechanomyography (MMG) and Triggered Electromyography (EMG) for detecting cortical breaches during lower spine fusion surgery. Unlike standard techniques, MMG uses mechanical vibrations from muscle contractions, potentially offering a more direct and sensitive way to detect breaches. EMG, on the other hand, measures electrical activity in muscles, providing a different angle on breach detection. By using both methods, researchers aim to improve the accuracy and safety of spine surgeries, which could lead to better outcomes for patients with low back pain.

What evidence suggests that MMG and EMG are effective for detecting cortical breaches in low back pain surgery?

This trial will compare mechanomyography (MMG) and triggered electromyography (EMG) for cortical breach detection during lower spine fusion surgery. Studies have shown that both MMG and EMG effectively locate nerves during surgery to prevent accidental nerve pinching by screws. MMG has proven accurate in preventing these incidents and shows promise in protecting nerve roots during spine surgery. Similarly, EMG has lowered the rate of these accidents, demonstrating high accuracy in screw placement in the lower back. Both techniques have FDA approval and aim to make surgeries safer by avoiding nerve damage. ^{1 2 3 4 5}

Who Is on the Research Team?

Francis Farhadi, MD, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12547453/

Prospective evaluation of mechanomyography versus ... tEMG and MMG demonstrate high and equivalent accuracy to detect cortical breaches intraoperatively. Adequate utilization of either technique may enhance pedicle ...

2. withpower.com withpower.com/trial/phase-low-back-disorder-4-2022-4aab5?fbclid=IwZXh0bgNhZW0CMTEAAR4yLI5D3-7L_fSicQopEm4B45JafJJpy_w1KbvaYX1rToqsqcm8b4pxz5nIQA_aem_ljJPgBctjLNv-tmzf4zoHg

MMG vs EMG for Cortical Breach Detection in Low Back Pain The purpose of this study is to determine how well mechanomyography (MMG) and electromyography (EMG) prevent cortical bone breaches, or the pinching of a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11856354/

Implementation and Feasibility of Mechanomyography in ... For cervical foraminotomies and far lateral discectomies, MMG showed promising results in determining adequate decompression of the nerve root.

4. researchgate.net researchgate.net/publication/388348567_Implementation_and_Feasibility_of_Mechanomyography_in_Minimally_Invasive_Spine_Surgery

Implementation and Feasibility of Mechanomyography in ... For cervical foraminotomies and far lateral discectomies, MMG showed promising results in determining adequate decompression of the nerve root.

5. pure.johnshopkins.edu pure.johnshopkins.edu/en/publications/mechanomyography-for-intraoperative-assessment-of-cortical-breach

Mechanomyography for Intraoperative Assessment of ... Objective: We sought to determine the utility of mechanomyography (MMG) in detecting and preventing pedicle breach in instrumented lumbar spine surgery.