N/A
N=65
MMG vs. EMG for Cortical Breach Detection
Low Back Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05352048 ↗Enrolled (actual)
65
Serious AEs
4.9%
Results posted
Aug 2025
Primary outcome: Primary: Success of Pedicle Screw Trajectories — 296; 5; 2 Screws
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Triggered Electromyography (Device); Mechanomyography (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Francis Farhadi
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success of Pedicle Screw Trajectories |
296; 5; 2 | — |
| SECONDARY Change From Baseline in the Numeric Rating Scale (NRS) Questionnaire for Pain. |
-3.80; -4.15 | — |
| SECONDARY Change From Baseline in the Oswestry Disability Index Version 2.1A |
-47.4 | — |
| SECONDARY Change From Baseline in the PROMIS Global-10 |
26.6; 14.6 | — |
| SECONDARY Change in the Short-From (SF-36) Health Survey |
— | — |
| SECONDARY Hospital Readmission at 30 Days |
3.28 | — |
| SECONDARY Hospital Readmission at 90 Days |
1.64 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05352048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.