Validation of Triggered EMG Values for Pedicle Screws Using a Powered Screwdriver

Study Overview
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Brief Summary
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Previous studies have shown how triggered electromyogram (EMG) pedicle screw stimulation can be used to effectively test correct pedicle screw placement in the lumbar and thoracic vertebrae. Most papers agree that if more than 6mA of current are needed to elicit a response the screw is correctly placed in the bone. If there is a response with less than 6mA there is a strong likelihood of a breach of the pedicle wall or invasion of the spinal canal. Typically this triggered EMG stimulation is done after all the screws have been placed with a ball-tipped probe and is paired with intraoperative fluoroscopy to ensure correct placement of the screws. Another method of testing the current for each screw is with a powered screwdriver, which can stimulate and give a reading as the surgeon places each screw. Both of these methods are currently used by surgeons, however the powered screwdriver has been found to be a faster method. The investigator's aim with this study is to compare these two methods of testing triggered EMG values. The investigators plan on doing this by testing each screw with both the ball-tipped probe and the powered screwdriver, in order to see if there are any statistically significant differences between the readings.

Detailed Description
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The purpose of the study is to compare two methods of testing triggered EMG values. All study measurements will be recorded during the surgical procedure. No follow up is required with the patient involved and no personal health information will be recorded from the patients.

Official Title
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Validation of Triggered EMG Values for Pedicle Screws Using a Powered Screwdriver

Conditions
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Scoliosis

Intervention / Treatment
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* Procedure: Spinal Fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between the ages of 8-21 years diagnosis of adolescent idiopathic scoliosis (AIS) scheduled to receive a spinal fusion Exclusion Criteria: diagnosis of any other type of scoliosis (infantile, juvenile, congenital, neuromuscular, etc)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adolescent idiopathic scoliosis<br>Patients with adolescent idiopathic scoliosis undergoing spinal fusion | Procedure: Spinal Fusion<br>* The investigators are studying the use of triggered EMG via the IPC POWEREASE screwdriver (Product Codes HBE, HWE, GWF) during spinal fusion surgery in adolescent idiopathic scoliosis by comparing it to the traditional triggered EMG OrthoMon probe system (Product Codes GWF, IKN).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triggered EMG value | The triggered EMG value the investigators are measuring is not being evaluated with respect to the individual patient. Rather, the investigators are studying the devices themselves so once all readings are collected (which will take readings from multiple screws in multiple patients) the outcome measure will be assessed. | Will be recorded during surgery, fully assessed after data collection is complete | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scoliosis, Pedicle screw, Neuromonitoring, EMG