MMG vs. EMG for Cortical Breach Detection (NCT05352048) | Clinical Trial Compass
CompletedNot Applicable
MMG vs. EMG for Cortical Breach Detection
United States65 participantsStarted 2022-08-02
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.