NeuroVision® Dynamic Screw Test Study

Degenerative Spinal Conditions Clinical Trial

Official title:

A Prospective Evaluation of the Dynamic Function of the NeuroVision® System for the Placement of Lumbar Pedicle Screws

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232517
• Other study ID #: NUVA.NV0804
• Status: Completed
• Phase: N/A
• First received: October 29, 2010
• Last updated: April 29, 2015
• Start date: March 2009
• Est. completion date: February 2012

Study information

• Verified date: April 2015
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Degenerative Spinal Conditions

Locations

Country	Name	City	State
United States	Aurora BayCare Medical Center	Green Bay	Wisconsin
United States	University of California, San Francisco	San Francisco	California
United States	Northwest Orthopaedic Specialists, PS	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivities/specificities of NeuroVision Basic and Dynamic Screw Test monitoring modalities to predict (1) pedicle breach and (2) neural injury		6 weeks postoperative	No
Secondary	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	No
Secondary	Intraoperative time (in minutes) taken to place Basic vs Dynamically tested screws.		Intraoperative	No
Secondary	Intraoperative fluoroscopy (in minutes) used to place Basic vs Dynamically tested screws.		Intraoperative	No