NeuroVision® Dynamic Screw Test Study

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Spinal Conditions

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Washington
    • Spokane, Washington, United States, 99208
      • Northwest Orthopaedic Specialists, PS
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54308
      • Aurora BayCare Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Surgical candidates for posterior instrumented lumbar fusion surgery

Description

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.

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivities/specificities of NeuroVision Basic and Dynamic Screw Test monitoring modalities to predict (1) pedicle breach and (2) neural injury	6 weeks postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
The change in subject self-reported pain ratings (Visual Analog Scales, leg and back pain) from the preoperative period through postoperative follow-up.	6 weeks postoperative
Intraoperative time (in minutes) taken to place Basic vs Dynamically tested screws.	Intraoperative
Intraoperative fluoroscopy (in minutes) used to place Basic vs Dynamically tested screws.	Intraoperative

Collaborators and Investigators

• Sponsor: NuVasive

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: October 29, 2010
• First Submitted That Met QC Criteria: October 29, 2010
• First Posted (Estimate): November 2, 2010

Study Record Updates

• Last Update Posted (Estimate): April 30, 2015
• Last Update Submitted That Met QC Criteria: April 29, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: NUVA.NV0804