Degenerative Spinal ConditionsNCT01232517
NeuroVision® Dynamic Screw Test Study
An observational study of Degenerative Spinal Conditions, run by NuVasive at 3 sites in United States.
Trial summary
The purpose of this research study is to gather information about the NeuroVision System (which is FDA cleared for this indication) during the placement of pedicle screws. NeuroVision is a machine that monitors nerve activity during surgery and will alert the surgeon if there are any nerve-related issues during screw… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Spinal Conditions
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2009to Feb 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical candidates for posterior instrumented lumbar fusion surgery
Who may be able to join
- Male and female patients who are at least 18 years of age.
- Surgical candidates for posterior instrumented lumbar fusion surgery.
- Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study.
Who cannot join
- Patients with underlying neurological disease or neurological deficits that are not associated with the condition for which they are seeking surgical intervention.
- Patients who have had previous instrumented surgery at the involved lumbar level.
- Participants in any other clinical study involving an investigational device or drug within 30 days of enrollment into the current study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54308
University of California, San Francisco
San Francisco, California, 94143
Northwest Orthopaedic Specialists, PS
Spokane, Washington, 99208
About this study
Official title: A Prospective Evaluation of the Dynamic Function of the NeuroVision® System for the Placement of Lumbar Pedicle Screws
The purpose of this research study is to gather information about the NeuroVision System (which is FDA cleared for this indication) during the placement of pedicle screws. NeuroVision is a machine that monitors nerve activity during surgery and will alert the surgeon if there are any nerve-related issues during screw placement. The use of nerve monitoring is standard of care at most centers during spine surgery. The standard monitoring for screws placed is performed after the screw is placed, to ensure it is well positioned in the bone (if it is not, the screw may be removed and/or repositioned). The NeuroVision System has a novel feature called "Dynamic Screw Test" that allows for that monitoring to be performed as the screw is placed, rather than after the fact. This study is being done to determine if this real-time monitoring of screw placement provides beneficial additional information to the operating surgeon to prevent misplacement of screws before it happens.
- Conditions
- Degenerative Spinal Conditions
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivities/specificities of NeuroVision Basic and Dynamic Screw Test monitoring modalities to predict (1) pedicle breach and (2) neural injury
Measured: 6 weeks postoperative
Secondary outcomes (3)
The change in subject self-reported pain ratings (Visual Analog Scales, leg and back pain) from the preoperative period through postoperative follow-up.
Measured: 6 weeks postoperative
Intraoperative time (in minutes) taken to place Basic vs Dynamically tested screws.
Measured: Intraoperative
Intraoperative fluoroscopy (in minutes) used to place Basic vs Dynamically tested screws.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startMar 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Spinal ConditionsStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232517
- Sponsor's protocol ID
- NUVA.NV0804
- Status last verified
- Dec 2025
- First submitted
- 29 Oct 2010
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of the Dynamic Function of the NeuroVision® System for the Placement of Lumbar Pedicle Screws
- ClinicalTrials.gov ID
- NCT01232517
- Acronym / sponsor ID
- NUVA.NV0804
- Conditions
- Degenerative Spinal Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Nov 2010 (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.
The purpose of this research study is to gather information about the NeuroVision System (which is FDA cleared for this indication) during the placement of pedicle screws. NeuroVision is a machine that monitors nerve activity during surgery and will alert the surgeon if there are any nerve-related issues during screw placement. The use of nerve monitoring is standard of care at most centers during spine surgery. The standard monitoring for screws placed is performed after the screw is placed, to ensure it is well positioned in the bone (if it is not, the screw may be removed and/or repositioned). The NeuroVision System has a novel feature called "Dynamic Screw Test" that allows for that monitoring to be performed as the screw is placed, rather than after the fact. This study is being done to determine if this real-time monitoring of screw placement provides beneficial additional information to the operating surgeon to prevent misplacement of screws before it happens.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical candidates for posterior instrumented lumbar fusion surgery
Key inclusion criteria (3 listed)
- Male and female patients who are at least 18 years of age.
- Surgical candidates for posterior instrumented lumbar fusion surgery.
- Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Patients with underlying neurological disease or neurological deficits that are not associated with the condition for which they are seeking surgical intervention.
- Patients who have had previous instrumented surgery at the involved lumbar level.
- Participants in any other clinical study involving an investigational device or drug within 30 days of enrollment into the current study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivities/specificities of NeuroVision Basic and Dynamic Screw Test monitoring modalities to predict (1) pedicle breach and (2) neural injury
Time frame: 6 weeks postoperative
3 secondary outcomes
The change in subject self-reported pain ratings (Visual Analog Scales, leg and back pain) from the preoperative period through postoperative follow-up.
Time frame: 6 weeks postoperative
Intraoperative time (in minutes) taken to place Basic vs Dynamically tested screws.
Time frame: Intraoperative
Intraoperative fluoroscopy (in minutes) used to place Basic vs Dynamically tested screws.
Time frame: Intraoperative
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 24 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Spinal Conditions, run by NuVasive at 3 sites 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 3 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 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Sensitivities/specificities of NeuroVision Basic and Dynamic Screw Test monitoring modalities to predict (1) pedicle breach and (2) neural injury (time frame: 6 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025.