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

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Scoliosis

Treatments

Procedure: Spinal Fusion

Study type

Observational

Funder types

Other

Identifiers

NCT02064101
13-2281

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

8 to 21 years old

Volunteers

No Healthy Volunteers

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)

Trial design

27 participants in 1 patient group

Adolescent idiopathic scoliosis
Description:
Patients with adolescent idiopathic scoliosis undergoing spinal fusion
Treatment:
Procedure: Spinal Fusion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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