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Diagnostic Device

MMG vs EMG for Cortical Breach Detection in Low Back Pain

N/A

Recruiting

Led By H. Francis Farhadi, MD, PhD

Research Sponsored by H. Francis Farhadi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unresponsive to conservative care for a minimum of 6 months

Scheduled to undergo a one-, two-, or three-level posterolateral spinal fusion surgery using Depuy Synthes Expedium pedicle screw instrumentation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks and 3 months after surgery

Awards & highlights

Study Summary

This trial will compare the accuracy of MMG vs EMG in preventing cortical bone breaches during lower back surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since MMG and EMG are monitoring devices rather than treatments or drugs, they don't have typical side effects. However, there may be risks associated with their use during surgery such as discomfort at the sensor sites or inaccurate readings leading to potential nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks and 3 months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks and 3 months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks and 3 months after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Success of Pedicle Screw Trajectories

Secondary outcome measures

Change in the Numeric Rating Scale (NRS) Questionnaire for pain.

Change in the Oswestry Disability Index version 2.1A

Change in the PROMIS Global-10

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intraoperative MMG vs EMG for cortical breach detectionExperimental Treatment2 Interventions

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Francis FarhadiLead Sponsor

2 Previous Clinical Trials

310 Total Patients Enrolled

DePuy SynthesIndustry Sponsor

30 Previous Clinical Trials

4,849 Total Patients Enrolled

H. Francis Farhadi, MD, PhDPrincipal InvestigatorUniversity of Kentucky

4 Previous Clinical Trials

1,317 Total Patients Enrolled

Media Library

Mechanomyography (Diagnostic Device) Clinical Trial Eligibility Overview. Trial Name: NCT05352048 — N/A

Low Back Pain Research Study Groups: Intraoperative MMG vs EMG for cortical breach detection

Low Back Pain Clinical Trial 2023: Mechanomyography Highlights & Side Effects. Trial Name: NCT05352048 — N/A

Mechanomyography (Diagnostic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05352048 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What proportion of individuals have chosen to partake in this medical experiment?

"Absolutely. Clinicaltrials.gov documents confirm that this clinical research, first published on August 2nd 2022, is presently recruiting volunteers. A total of 75 patients are required to be enrolled from 1 study location."

Answered by AI

Is the eligibility for this experiment limited to individuals aged twenty and under?

"The eligible participants in this trial must be aged between 18 and 80 years."

Answered by AI

Is it feasible for me to join this medical experiment?

"This research is recruiting 75 subjects suffering from low back pain, aged 18 to 80. The crucial criteria for enrollment are the necessity of a posterolateral spinal fusion surgery performed with Depuy Synthes Expedium pedicle screws, an obstacle to conservative care therapy for at least 6 months, and the mental and physical capacity to consent fully and comply with the protocol's rules."

Answered by AI

Are there any available slots for participants in this clinical research?

"Clinicaltrials.gov has confirmed that this medical research is searching for participants, with the trial being first posted on August 2nd 2022 and updated later the same day."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MMG vs. EMG for Cortical Breach Detection

H. Francis Farhadi 2022. "MMG vs. EMG for Cortical Breach Detection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05352048.