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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064101
• Other study ID #: 13-2281
• Status: Completed
• Phase: N/A
• First received: February 13, 2014
• Last updated: October 24, 2016
• Start date: February 2014
• Est. completion date: July 2015

Study information

• Verified date: October 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 21 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Scoliosis

Intervention

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).

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (6)

de Blas G, Barrios C, Regidor I, Montes E, Burgos J, Pizá-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. — View Citation

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. Review. — View Citation

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. — View Citation

Regidor I, de Blas G, Barrios C, Burgos J, Montes E, García-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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triggered EMG value	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	Yes