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

NCT02064101 | Completed

• 1 other identifier: 13-2281
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis

Keywords

Scoliosis; EMG; Pedicle screw; Neuromonitoring

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Adolescent idiopathic scoliosis

Patients with adolescent idiopathic scoliosis undergoing spinal fusion

Procedure: Spinal Fusion

Interventions

Spinal Fusion PROCEDURE

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).

Adolescent idiopathic scoliosis

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• between the ages of 8-21 years
• diagnosis of adolescent idiopathic scoliosis (AIS)
• scheduled to receive a spinal fusion

You may not qualify if:

• diagnosis of any other type of scoliosis (infantile, juvenile, congenital, neuromuscular, etc)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (6)

• 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.

  PMID: 12634564 BACKGROUND

• 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.

  PMID: 12642768 BACKGROUND

• 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.

  PMID: 21512840 BACKGROUND

• 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.

  PMID: 22024903 BACKGROUND

• 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.

  PMID: 21170665 BACKGROUND

• 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.

  PMID: 22469677 BACKGROUND

MeSH Terms

Conditions

Scoliosis

Interventions

Spinal Fusion

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthrodesis; Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Sumeet Garg, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 17, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

US (1)