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NeuroVision® Dynamic Screw Test Study

NCT ID: NCT01232517

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Degenerative Spinal Conditions

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Male and female patients who are at least 18 years of age.
2. Surgical candidates for posterior instrumented lumbar fusion surgery.
3. Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study.

Exclusion Criteria

1. Patients with underlying neurological disease or neurological deficits that are not associated with the condition for which they are seeking surgical intervention.
2. Patients who have had previous instrumented surgery at the involved lumbar level.
3. Participants in any other clinical study involving an investigational device or drug within 30 days of enrollment into the current study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NuVasive

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Northwest Orthopaedic Specialists, PS

Spokane, Washington, United States

Site Status

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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NUVA.NV0804

Identifier Type: -

Identifier Source: org_study_id