NCT02064101

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 8 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Scoliosis

Interventions

Type	Name	Description
PROCEDURE	Spinal Fusion	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).

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-02-17
• Last updated: 2016-10-25

Locations

1 site across 1 country: United States