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

October 24, 2016 updated by: University of Colorado, Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients between the ages of 8-21 years of age with a diagnosis of adolescent idiopathic scoliosis (AIS) who will be receiving a spinal fusion.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adolescent idiopathic scoliosis
Patients with adolescent idiopathic scoliosis undergoing spinal fusion
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Triggered EMG value
Time Frame: 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.
Will be recorded during surgery, fully assessed after data collection is complete

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria

February 13, 2014

First Posted (ESTIMATE)

February 17, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-2281

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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