- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02064101
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
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
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
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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 |
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Adolescent idiopathic scoliosis
Patients with adolescent idiopathic scoliosis undergoing spinal fusion
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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).
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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
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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.
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Will be recorded during surgery, fully assessed after data collection is complete
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Raynor BL, Lenke LG, Kim Y, Hanson DS, Wilson-Holden TJ, Bridwell KH, Padberg AM. Can triggered electromyograph thresholds predict safe thoracic pedicle screw placement? Spine (Phila Pa 1976). 2002 Sep 15;27(18):2030-5. doi: 10.1097/00007632-200209150-00012.
- Shi YB, Binette M, Martin WH, Pearson JM, Hart RA. Electrical stimulation for intraoperative evaluation of thoracic pedicle screw placement. Spine (Phila Pa 1976). 2003 Mar 15;28(6):595-601. doi: 10.1097/01.BRS.0000049926.43292.93.
- Regidor I, de Blas G, Barrios C, Burgos J, Montes E, Garcia-Urquiza S, Hevia E. Recording triggered EMG thresholds from axillary chest wall electrodes: a new refined technique for accurate upper thoracic (T2-T6) pedicle screw placement. Eur Spine J. 2011 Oct;20(10):1620-5. doi: 10.1007/s00586-011-1800-z. Epub 2011 Apr 22.
- de Blas G, Barrios C, Regidor I, Montes E, Burgos J, Piza-Vallespir G, Hevia E. Safe pedicle screw placement in thoracic scoliotic curves using t-EMG: stimulation threshold variability at concavity and convexity in apex segments. Spine (Phila Pa 1976). 2012 Mar 15;37(6):E387-95. doi: 10.1097/BRS.0b013e31823b077b.
- Samdani AF, Tantorski M, Cahill PJ, Ranade A, Koch S, Clements DH, Betz RR, Asghar J. Triggered electromyography for placement of thoracic pedicle screws: is it reliable? Eur Spine J. 2011 Jun;20(6):869-74. doi: 10.1007/s00586-010-1653-x. Epub 2010 Dec 18.
- Nichols GS, Manafov E. Utility of electromyography for nerve root monitoring during spinal surgery. J Clin Neurophysiol. 2012 Apr;29(2):140-8. doi: 10.1097/WNP.0b013e31824cece6.
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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