ScoliosisNCT02064101
Validation of Triggered EMG Values for Pedicle Screws Using a Powered Screwdriver
An observational study of Scoliosis, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Spinal Fusion
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- between the ages of 8-21 years
- diagnosis of adolescent idiopathic scoliosis (AIS)
- scheduled to receive a spinal fusion
Who cannot join
- diagnosis of any other type of scoliosis (infantile, juvenile, congenital, neuromuscular, etc)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Scoliosis
- Being tested
- Spinal Fusion
- Keywords
- Scoliosis, EMG, Pedicle screw, Neuromonitoring
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal FusionProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Adolescent idiopathic scoliosis | Patients with adolescent idiopathic scoliosis undergoing spinal fusion Receives: Procedure: Spinal Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Will be recorded during surgery, fully assessed after data collection is complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumeet Garg, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064101
- Sponsor's protocol ID
- 13-2281
- Status last verified
- Oct 2016
- First submitted
- 13 Feb 2014
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 12634564Shi 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.
PubMed 12642768Regidor 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.
PubMed 21512840de 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.
PubMed 22024903Samdani 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.
PubMed 21170665Nichols 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.
PubMed 22469677
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Triggered EMG Values for Pedicle Screws Using a Powered Screwdriver
- ClinicalTrials.gov ID
- NCT02064101
- Acronym / sponsor ID
- 13-2281
- Conditions
- Scoliosis
- Keywords
- Scoliosis, EMG, Pedicle screw, Neuromonitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent idiopathic scoliosis | – | Procedure: Spinal FusionPatients with adolescent idiopathic scoliosis undergoing spinal fusion |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- between the ages of 8-21 years
- diagnosis of adolescent idiopathic scoliosis (AIS)
- scheduled to receive a spinal fusion
Key exclusion criteria (1 listed)
- diagnosis of any other type of scoliosis (infantile, juvenile, congenital, neuromuscular, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal FusionThe 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). | Procedure or surgery | Adolescent idiopathic scoliosis |
Primary outcome
Triggered EMG value
Time frame: Will be recorded during surgery, fully assessed after data collection is complete
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Background: PubMed 12634564Raynor 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.
- Background: PubMed 12642768Shi 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.
- Background: PubMed 21512840Regidor 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.
- Background: PubMed 22024903de 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.
- Background: PubMed 21170665Samdani 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.
- Background: PubMed 22469677Nichols 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumeet Garg, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triggered EMG value (time frame: Will be recorded during surgery, fully assessed after data collection is complete). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02064101, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.