Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02064101
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Scoliosis Procedure: Spinal Fusion

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Triggered EMG Values for Pedicle Screws Using a Powered Screwdriver
Study Start Date : February 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

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).




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064101


Locations
Layout table for location information
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Sumeet Garg, MD University of Colorado, Denver

Publications:
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02064101     History of Changes
Other Study ID Numbers: 13-2281
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by University of Colorado, Denver:
Scoliosis
EMG
Pedicle screw
Neuromonitoring

Additional relevant MeSH terms:
Layout table for MeSH terms
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases