Trial Outcomes & Findings for MMG vs. EMG for Cortical Breach Detection (NCT NCT05352048)
NCT ID: NCT05352048
Last Updated: 2025-08-19
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
1 hour
Results posted on
2025-08-19
Participant Flow
Participant milestones
| Measure |
Intraoperative MMG vs EMG for Cortical Breach Detection
Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery.
Triggered Electromyography: 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.
Mechanomyography: 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.
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Intraoperative MMG vs EMG for Cortical Breach Detection
Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery.
Triggered Electromyography: 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.
Mechanomyography: 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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
did not get EMG-MMG readings intraoperatively
|
3
|
Baseline Characteristics
MMG vs. EMG for Cortical Breach Detection
Baseline characteristics by cohort
| Measure |
Intraoperative MMG vs EMG for Cortical Breach Detection
n=61 Participants
Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery.
Triggered Electromyography: 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.
Mechanomyography: 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.
|
|---|---|
|
Age, Continuous
|
61.26 years
STANDARD_DEVIATION 9.62 • n=99 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 hourPatients 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
Outcome measures
| Measure |
Intraoperative MMG vs EMG for Cortical Breach Detection
n=303 Screws
Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery.
Triggered Electromyography: 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.
Mechanomyography: 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.
|
|---|---|
|
Success of Pedicle Screw Trajectories
Grade A or B
|
296 Screws
|
|
Success of Pedicle Screw Trajectories
Grade C
|
5 Screws
|
|
Success of Pedicle Screw Trajectories
Grade E
|
2 Screws
|
SECONDARY outcome
Timeframe: 3 months after surgeryThis 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 \[(Average measure at 3 months - Average measure at baseline)/Average measure at baseline\].
Outcome measures
| Measure |
Intraoperative MMG vs EMG for Cortical Breach Detection
n=61 Participants
Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery.
Triggered Electromyography: 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.
Mechanomyography: 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.
|
|---|---|
|
Change From Baseline in the Numeric Rating Scale (NRS) Questionnaire for Pain.
NRS Leg Pain
|
-4.15 score on a scale
Standard Deviation 3.41
|
|
Change From Baseline in the Numeric Rating Scale (NRS) Questionnaire for Pain.
NRS Back Pain
|
-3.80 score on a scale
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: 3 months after surgeryThis 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 \[(Average measure at 3 months - Average measure at baseline)/Average measure at baseline\]
Outcome measures
| Measure |
Intraoperative MMG vs EMG for Cortical Breach Detection
n=61 Participants
Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery.
Triggered Electromyography: 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.
Mechanomyography: 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.
|
|---|---|
|
Change From Baseline in the Oswestry Disability Index Version 2.1A
|
-47.4 percentage of disability
Standard Deviation 34.2
|
SECONDARY outcome
Timeframe: 3 months after surgeryThis 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 \[(Average measure at 3 months - Average measure at baseline)/Average measure at baseline\]
Outcome measures
| Measure |
Intraoperative MMG vs EMG for Cortical Breach Detection
n=61 Participants
Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery.
Triggered Electromyography: 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.
Mechanomyography: 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.
|
|---|---|
|
Change From Baseline in the PROMIS Global-10
Physical Health
|
26.6 percentage of quality of life
Standard Deviation 38
|
|
Change From Baseline in the PROMIS Global-10
Mental Health
|
14.6 percentage of quality of life
Standard Deviation 28
|
SECONDARY outcome
Timeframe: 6 weeks and 3 months after surgeryPopulation: Survey data never collected due to redundancy and overlapping questions contained in the PROMIS-10 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysPercent of patients undergoing hospital readmission 30 days following the procedure.
Outcome measures
| Measure |
Intraoperative MMG vs EMG for Cortical Breach Detection
n=61 Participants
Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery.
Triggered Electromyography: 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.
Mechanomyography: 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.
|
|---|---|
|
Hospital Readmission at 30 Days
|
3.28 percentage of participants
|
SECONDARY outcome
Timeframe: 90 daysPercent of patients undergoing hospital readmission 90 days following the procedure.
Outcome measures
| Measure |
Intraoperative MMG vs EMG for Cortical Breach Detection
n=61 Participants
Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery.
Triggered Electromyography: 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.
Mechanomyography: 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.
|
|---|---|
|
Hospital Readmission at 90 Days
|
1.64 Percentage of participants
|
Adverse Events
Intraoperative MMG vs EMG for Cortical Breach Detection
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intraoperative MMG vs EMG for Cortical Breach Detection
n=61 participants at risk
Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery.
Triggered Electromyography: 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.
Mechanomyography: 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.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
ankle fracture
|
1.6%
1/61 • 3 months
|
|
Blood and lymphatic system disorders
Lower extremity deep venous thrombosis
|
1.6%
1/61 • 3 months
|
|
Blood and lymphatic system disorders
Stroke
|
1.6%
1/61 • 3 months
|
Other adverse events
| Measure |
Intraoperative MMG vs EMG for Cortical Breach Detection
n=61 participants at risk
Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery.
Triggered Electromyography: 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.
Mechanomyography: 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.
|
|---|---|
|
Blood and lymphatic system disorders
Upper Limb Swelling
|
1.6%
1/61 • 3 months
|
|
Blood and lymphatic system disorders
Low hemoglobin
|
1.6%
1/61 • 3 months
|
|
Blood and lymphatic system disorders
Postoperative anemia
|
1.6%
1/61 • 3 months
|
|
Cardiac disorders
Hypotension
|
1.6%
1/61 • 3 months
|
|
Eye disorders
Left eye pain
|
1.6%
1/61 • 3 months
|
|
Gastrointestinal disorders
Bowel Impaction
|
1.6%
1/61 • 3 months
|
|
Gastrointestinal disorders
Postoperative ileus
|
1.6%
1/61 • 3 months
|
|
General disorders
Mechanical Fall
|
4.9%
3/61 • 3 months
|
|
Infections and infestations
Tooth Abscess
|
1.6%
1/61 • 3 months
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/61 • 3 months
|
|
Infections and infestations
Suture abscess
|
1.6%
1/61 • 3 months
|
|
Metabolism and nutrition disorders
High fasting blood glucose
|
1.6%
1/61 • 3 months
|
|
Nervous system disorders
Memory Impairment
|
1.6%
1/61 • 3 months
|
|
Nervous system disorders
Right foot drop
|
1.6%
1/61 • 3 months
|
|
Nervous system disorders
Postoperative foot drop
|
1.6%
1/61 • 3 months
|
|
Nervous system disorders
Left sided sciatic pain
|
1.6%
1/61 • 3 months
|
|
Surgical and medical procedures
Superficial wound dehiscence
|
3.3%
2/61 • 3 months
|
|
Surgical and medical procedures
Wound dehiscence
|
1.6%
1/61 • 3 months
|
|
Surgical and medical procedures
Intraoperative CSF leak
|
1.6%
1/61 • 3 months
|
|
Vascular disorders
Posterior tibial vein deep venous thrombosis
|
1.6%
1/61 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place