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| Name | Class |
|---|---|
| DePuy Synthes | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triggered Electromyography | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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]. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. Francis Farhadi, MD, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.
| Posted | Count of Units | Screws | 1 hour | Screws | Screws |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ankle fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Limb Swelling | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francis Farhadi | University of Kentucky | 859-323-5661 | francis.farhadi@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 2, 2024 | Jul 21, 2025 | Prot_SAP_ICF_001.pdf |
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| Mechanomyography | Device | 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. |
|
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| 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] | 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] | 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. | 6 weeks and 3 months after surgery |
| Hospital Readmission at 30 Days | Percent of patients undergoing hospital readmission 30 days following the procedure. | 30 days |
| Hospital Readmission at 90 Days | Percent of patients undergoing hospital readmission 90 days following the procedure. | 90 days |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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]. | Posted | Mean | Standard Deviation | score on a scale | 3 months after surgery |
|
|
|
| Secondary | 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] | Posted | Mean | Standard Deviation | percentage of disability | 3 months after surgery |
|
|
|
| Secondary | 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] | Posted | Mean | Standard Deviation | percentage of quality of life | 3 months after surgery |
|
|
|
| Secondary | 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. | Survey data never collected due to redundancy and overlapping questions contained in the PROMIS-10 survey. | Posted | 6 weeks and 3 months after surgery |
|
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| Secondary | Hospital Readmission at 30 Days | Percent of patients undergoing hospital readmission 30 days following the procedure. | Posted | Number | percentage of participants | 30 days |
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|
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| Secondary | Hospital Readmission at 90 Days | Percent of patients undergoing hospital readmission 90 days following the procedure. | Posted | Number | Percentage of participants | 90 days |
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| 0 |
| 61 |
| 3 |
| 61 |
| 23 |
| 61 |
| Lower extremity deep venous thrombosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Stroke | Blood and lymphatic system disorders | Systematic Assessment |
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| Low hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
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| Postoperative anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Hypotension | Cardiac disorders | Systematic Assessment |
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| Left eye pain | Eye disorders | Systematic Assessment |
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| Bowel Impaction | Gastrointestinal disorders | Systematic Assessment |
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| Postoperative ileus | Gastrointestinal disorders | Systematic Assessment |
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| Mechanical Fall | General disorders | Systematic Assessment |
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| Tooth Abscess | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Suture abscess | Infections and infestations | Systematic Assessment |
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| High fasting blood glucose | Metabolism and nutrition disorders | Systematic Assessment |
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| Memory Impairment | Nervous system disorders | Systematic Assessment |
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| Right foot drop | Nervous system disorders | Systematic Assessment |
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| Postoperative foot drop | Nervous system disorders | Systematic Assessment |
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| Left sided sciatic pain | Nervous system disorders | Systematic Assessment |
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| Superficial wound dehiscence | Surgical and medical procedures | Systematic Assessment |
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| Wound dehiscence | Surgical and medical procedures | Systematic Assessment |
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| Intraoperative CSF leak | Surgical and medical procedures | Systematic Assessment |
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| Posterior tibial vein deep venous thrombosis | Vascular disorders | Systematic Assessment |
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