NeuroVision® Dynamic Screw Test Study

Completed

Conditions studied: Degenerative Spinal Conditions

In brief

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.

Key facts

Study ID

NCT01232517

Run by

NuVasive

People needed

60

Starts

2009-03-01

Expected to finish

2012-02-01

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Northwest Orthopaedic Specialists, PS — Spokane, Washington, United States
• Aurora BayCare Medical Center — Green Bay, Wisconsin, United States

Full record on ClinicalTrials.gov

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