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MMG vs. EMG for Cortical Breach Detection

Sponsor
H. Francis Farhadi (Other)
Overall Status
Recruiting
CT.gov ID
NCT05352048
Collaborator
DePuy Synthes (Industry)
75
Enrollment
1
Location
1
Arm
30.9
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Triggered Electromyography
  • Device: Mechanomyography
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Prospective Evaluation of Mechanomyography Versus Triggered Electromyography for Intraoperative Assessment of Cortical Breaches During Instrumented Lumbar Spine Surgery
Actual Study Start Date :
Aug 2, 2022
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Device: 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.

Device: 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.
Other Names:
  • SENTIO MMG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Success of Pedicle Screw Trajectories [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

    Secondary Outcome Measures

    1. Change in the Numeric Rating Scale (NRS) Questionnaire for pain. [6 weeks and 3 months after surgery]

      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 neck, back, arms, and legs.

    2. Change in the Oswestry Disability Index version 2.1A [6 weeks and 3 months after surgery]

      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.

    3. Change in the PROMIS Global-10 [6 weeks and 3 months after surgery]

      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.

    4. Change in the Short-From (SF-36) Health Survey [6 weeks and 3 months after surgery]

      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.

    5. Hospital Readmission at 30 days [30 days]

      Percent of patients undergoing hospital readmission 30 days following the procedure.

    6. Hospital Readmission at 90 days [90 days]

      Percent of patients undergoing hospital readmission 90 days following the procedure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kentucky Lexington Kentucky United States 40536

    Sponsors and Collaborators

    • H. Francis Farhadi
    • DePuy Synthes

    Investigators

    • Principal Investigator: H. Francis Farhadi, MD, PhD, University of Kentucky

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    H. Francis Farhadi, Associate Professor, University of Kentucky
    ClinicalTrials.gov Identifier:
    NCT05352048
    Other Study ID Numbers:
    • 76122
    First Posted:
    Apr 28, 2022
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by H. Francis Farhadi, Associate Professor, University of Kentucky
    Lower back surgery
    Lumbar fusion

    Study Results

    No Results Posted as of Aug 4, 2022