NeuroVision® Dynamic Screw Test Study

Completed

• Conditions: Degenerative Spinal Conditions

• Registration Number: NCT01232517
• Lead Sponsor: NuVasive

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-10-29
• Study First Submitted QC: 2010-10-29
• Study First Posted: 2010-11-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (3)

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