NeuroVision® Dynamic Screw Test Study

This study has been completed.
Sponsor:
Information provided by:
NuVasive
ClinicalTrials.gov Identifier:
NCT01232517
First received: October 29, 2010
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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.


Condition
Degenerative Spinal Conditions

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective Evaluation of the Dynamic Function of the NeuroVision® System for the Placement of Lumbar Pedicle Screws

Further study details as provided by NuVasive:

Enrollment: 60
Study Start Date: March 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Surgical candidates for posterior instrumented lumbar fusion surgery

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232517

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Washington
Northwest Orthopaedic Specialists, PS
Spokane, Washington, United States, 99208
United States, Wisconsin
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54308
Sponsors and Collaborators
NuVasive
  More Information

No publications provided

Responsible Party: Kelli Howell, MS Director, Clinical Resources, NuVasive, Inc.
ClinicalTrials.gov Identifier: NCT01232517     History of Changes
Other Study ID Numbers: NUVA.NV0804
Study First Received: October 29, 2010
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014