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Completed

NCT Number: NCT01232517

NeuroVision® Dynamic Screw Test Study

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.

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Key information

Conditions

Degenerative Spinal Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Intraoperative time (in minutes) taken to place Basic vs Dynamically tested screws.

    Time frame: Intraoperative

  3. Intraoperative fluoroscopy (in minutes) used to place Basic vs Dynamically tested screws.

    Time frame: Intraoperative

Sponsors and collaborators

Lead sponsor

NuVasive

Industry

Registry information

Official study title

A Prospective Evaluation of the Dynamic Function of the NeuroVision® System for the Placement of Lumbar Pedicle Screws

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 2, 2010
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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