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

Completed

• Conditions: Scoliosis
• Interventions: Procedure: Spinal Fusion

• Registration Number: NCT02064101
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-17
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• between the ages of 8-21 years
• diagnosis of adolescent idiopathic scoliosis (AIS)
• scheduled to receive a spinal fusion

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Exclusion Criteria

• diagnosis of any other type of scoliosis (infantile, juvenile, congenital, neuromuscular, etc)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adolescent idiopathic scoliosis	Spinal Fusion	Patients with adolescent idiopathic scoliosis undergoing spinal fusion

Primary Outcome Measures

Name	Time	Method
Triggered EMG value	Will be recorded during surgery, fully assessed after data collection is complete	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.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States