Low Back DisorderNCT05352048
MMG vs. EMG for Cortical Breach Detection
A study testing Triggered Electromyography and Mechanomyography in people with Low Back Disorder, run by Francis Farhadi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Disorder
- What is being tested?
- Triggered Electromyography and Mechanomyography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2022to 6 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Mechanomyography Versus Triggered Electromyography for Intraoperative Assessment of Cortical Breaches During Instrumented Lumbar Spine Surgery
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.
- Conditions
- Low Back Disorder
- Being tested
- Triggered Electromyography, Mechanomyography
- Keywords
- Lower back surgery, Lumbar fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triggered ElectromyographyDevice
Triggered electromyography will be used during surgery to detect nerve impingement by pedicle screws used for spinal fusion. Threshold stimulation data from the device will be recorded.
MechanomyographyDevice
Also called SENTIO MMG
SENTIO MMG ball tip probe will be used during surgery to detect nerve impingement by pedicle screws used for spinal fusion. Threshold stimulation data from the device will be recorded, and the accuracy compared to the data from the triggered electromyography.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative MMG vs EMG for cortical breach detection | Experimental | Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery. Receives: Device: Triggered Electromyography; Device: Mechanomyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Pedicle Screw Trajectories
Patients with successful pedicle screw trajectories determined by the percentage of patients with A/B or C/D/E breaches.
- Grade A - No cortical breach (0 mm)
- Grade B - Pedicle cortical breach < 2 mm
- Grade C - Pedicle cortical breach = 2 to < 4 mm
- Grade D - Pedicle cortical breach = 4 to < 6 mm
- Grade E - Pedicle cortical breach = 6 mm
Measured: 1 hour
Secondary outcomes (6)
Change From Baseline in the Numeric Rating Scale (NRS) Questionnaire for Pain.
This survey is used to assess pain experienced by the subject and the severity of the pain. Types of pain include numbness, pins and needles, dull aching, burning sensation, muscle cramps, and stabbing pain. Pain severity is rated on a scale of 0-10 where 0 is no pain and 10 is the worst pain imaginable. Pain is assessed in the back and legs. Changes reported as percentages using the formula [(Average measure at 3 months - Average measure at baseline)/Average measure at baseline].
Measured: 3 months after surgery
Change From Baseline in the Oswestry Disability Index Version 2.1A
This survey is used to quantify disability for low back pain. There are five disability categories ranging from minimally disabled to crippled. The appropriate disability category is determined by the sum of the subjects points divided by the total possible points(50) times 100. This yields a % disabled score and this % determines the appropriate category designation. 0% is equated with no disability and 100% is the maximum disability possible. Changes reported as percentages using the formula [(Average measure at 3 months - Average measure at baseline)/Average measure at baseline]
Measured: 3 months after surgery
Change From Baseline in the PROMIS Global-10
This questionnaire is a 10 item patient reported tool used to quantify the patients general healthcare related quality of life. It assesses both physical and mental health and is scored as a percentage. Scores closer to 100% report a better quality of life than those who score lower. Changes reported as percentages using the formula [(Average measure at 3 months - Average measure at baseline)/Average measure at baseline]
Measured: 3 months after surgery
Change in the Short-From (SF-36) Health Survey
This survey quantifies how a patient feels about their health, and how well they are able to do common activities. This survey has 9 domains that assess the patients functional ability. The domains are scored as percentages from 0%-100% with 0% being severely limited and 100% being no deficits.
Measured: 6 weeks and 3 months after surgery
Hospital Readmission at 30 Days
Percent of patients undergoing hospital readmission 30 days following the procedure.
Measured: 30 days
Hospital Readmission at 90 Days
Percent of patients undergoing hospital readmission 90 days following the procedure.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start2 Aug 2022
- Primary completion9 Jul 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Back DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francis Farhadi
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes
- Responsible party
- Sponsor-investigator, Francis Farhadi, University of Kentucky
- Investigators
- H. Francis Farhadi, MD, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352048
- Sponsor's protocol ID
- 76122
- Status last verified
- Aug 2025
- First submitted
- 22 Apr 2022
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Mechanomyography Versus Triggered Electromyography for Intraoperative Assessment of Cortical Breaches During Instrumented Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT05352048
- Acronym / sponsor ID
- 76122
- Conditions
- Low Back Disorder
- Keywords
- Lower back surgery, Lumbar fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Francis FarhadiUniversity, hospital or other
- Collaborators
- DePuy Synthes
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative MMG vs EMG for cortical breach detection | Experimental | Device: Triggered Electromyography, Device: MechanomyographyParticipants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triggered ElectromyographyTriggered electromyography will be used during surgery to detect nerve impingement by pedicle screws used for spinal fusion. Threshold stimulation data from the device will be recorded. | Device | Intraoperative MMG vs EMG for cortical breach detection |
| MechanomyographyAlso: SENTIO MMGSENTIO MMG ball tip probe will be used during surgery to detect nerve impingement by pedicle screws used for spinal fusion. Threshold stimulation data from the device will be recorded, and the accuracy compared to the data from the triggered electromyography. | Device | Intraoperative MMG vs EMG for cortical breach detection |
Primary outcome
Success of Pedicle Screw Trajectories
Time frame: 1 hour
Patients with successful pedicle screw trajectories determined by the percentage of patients with A/B or C/D/E breaches. * Grade A - No cortical breach (0 mm) * Grade B - Pedicle cortical breach < 2 mm * Grade C - Pedicle cortical breach = 2 to < 4 mm * Grade D - Pedicle cortical breach = 4 to < 6 mm * Grade E - Pedicle cortical breach = 6 mm
6 secondary outcomes
Change From Baseline in the Numeric Rating Scale (NRS) Questionnaire for Pain.
Time frame: 3 months after surgery
Change From Baseline in the Oswestry Disability Index Version 2.1A
Time frame: 3 months after surgery
Change From Baseline in the PROMIS Global-10
Time frame: 3 months after surgery
Change in the Short-From (SF-36) Health Survey
Time frame: 6 weeks and 3 months after surgery
Hospital Readmission at 30 Days
Time frame: 30 days
Hospital Readmission at 90 Days
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. Francis Farhadi, MD, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triggered Electromyography and Mechanomyography in people with Low Back Disorder, run by Francis Farhadi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of Pedicle Screw Trajectories (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.