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NCT02064101 · ClinicalTrials.gov registry record
Validation of Triggered EMG Values for Pedicle Screws Using a Powered Screwdriver
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 27
- Enrollment target
NCT02064101: Completed study, sponsored by University of Colorado, Denver.
NCT02064101 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 27 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02064101 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 27 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- PROCEDURE Spinal Fusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-07 |
What the finished NCT02064101 record still lists
NCT02064101 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 27 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Spinal Fusion is the first listed.
NCT02064101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02064101 about?
NCT02064101 is a clinical study titled "Validation of Triggered EMG Values for Pedicle Screws Using a Powered Screwdriver". 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 pla...
What is the current status of trial NCT02064101?
This trial is currently completed. The enrollment target is 27 participants. The study started on 2014-02. Estimated completion is 2015-07.
What interventions are being tested in trial NCT02064101?
The interventions under investigation include: Spinal Fusion (PROCEDURE).
Who is sponsoring clinical trial NCT02064101?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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