NeuroVision® Dynamic Screw Test Study

NCT01232517 | Completed

• 1 other identifier: NUVA.NV0804
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Sensitivities/specificities of NeuroVision Basic and Dynamic Screw Test monitoring modalities to predict (1) pedicle breach and (2) neural injury

  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.

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Surgical candidates for posterior instrumented lumbar fusion surgery

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.

Sponsors & Collaborators

• NuVasive: lead

Study Sites (3)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Northwest Orthopaedic Specialists, PS

Spokane, Washington, 99208, United States

Location

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54308, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 2, 2010
• Study Start: March 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (3)