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NeuroVision® Dynamic Screw Test Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01232517
First Posted: November 2, 2010
Last Update Posted: April 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
NuVasive
  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:

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

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

Enrollment: 60
Study Start Date: March 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT01232517     History of Changes
Other Study ID Numbers: NUVA.NV0804
First Submitted: October 29, 2010
First Posted: November 2, 2010
Last Update Posted: April 30, 2015
Last Verified: April 2015