Multimodality Neuromonitoring in XLIF (NV in XLIF®)

July 14, 2014 updated by: NuVasive

Multimodality Neuromonitoring In eXtreme Lateral Interbody Fusion (XLIF®)

This is a prospective, non-randomized multi-center study to evaluate intraoperative neuromonitoring results in subjects who undergo eXtreme Lateral Interbody Fusion (XLIF) surgery at any number of levels inclusive of L4-5.

Study Overview

Status

Completed

Detailed Description

Subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will undergo neuromonitoring during the XLIF operation, as per standard care. They will then be re-evaluated immediately after surgery and at the first standard postoperative follow-up visit (6 weeks) to assess for presence of new neural deficit. If a new neural deficit is identified, the patient will be followed per the Investigator's standard follow-up schedule until symptoms have resolved (or are deemed permanent).

A total of 300 subjects will be enrolled in this study from multiple centers. The subjects will have degenerative conditions of the lumbar spine with planned treatment including XLIF surgery. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol is considered appropriate. All subjects must meet the inclusion/exclusion criteria below in order to be considered for enrollment.

Study Type

Observational

Enrollment (Actual)

323

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • San Juan, Puerto Rico, 00901
        • Caribbean Orthopaedic and Spine Institute
      • St. Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen
    • California
      • La Jolla, California, United States, 92037
        • Shiley Center for Orthopaedic Research
      • Orange, California, United States, 92868
        • UC Irvine Medical Center
    • Colorado
      • Durango, Colorado, United States, 81301
        • Durango Orthopaedics
    • Florida
      • Tampa, Florida, United States, 33606
        • USF Neurology and Neurosurgery
    • Georgia
      • Augusta, Georgia, United States, 30909
        • West Augusta Spine Specialists
      • Decatur, Georgia, United States, 30033
        • Georgia Spine and Neurosurgery Center
      • Marietta, Georgia, United States, 30060
        • Pinnacle Orthopaedics and Sports Medicine
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • McLean Country Orthopedics
      • Peoria, Illinois, United States, 61605
        • Illinois Neurological Institute
    • Missouri
      • Columbia, Missouri, United States, 65205
        • Columbia Orthopaedic Group
      • Jefferson City, Missouri, United States, 65101
        • Spine Midwest, Inc.
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Western Regional Center for Brain and Spine Surgery
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Oregon
      • Medford, Oregon, United States, 97504
        • South Oregon Spine Care
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • Univerisity of Pittsburgh Medical Center
    • South Carolina
      • Conway, South Carolina, United States, 29526
        • Coastal Orthopaedic Associates
    • Texas
      • San Antonio, Texas, United States, 78229
        • Spine Pain Be Gone Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study population will consist of patients from participating site locations.

Description

Inclusion Criteria:

  • Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless surgical treatment is clinically indicated earlier
  • Indicated for extreme lateral interbody fusion at any number of levels inclusive of L4-5
  • At least 18 years of age at the date of written informed consent
  • Able to undergo surgery based on physical exam, medical history and surgeon judgment
  • Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
  • Signed and dated informed consent form

Exclusion Criteria:

  • Patient has a mental or physical condition that would limit the ability to comply with study requirements
  • Patient is a prisoner
  • Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
  • Patient has an underlying neurological disease or neurological deficit that is not associated with the condition for which he/she is seeking surgical intervention (e.g., diabetic peripheral neuropathy)
  • Patient is participating in another clinical study that would confound study data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
NV in XLIF
This group will have the XLIF procedure done using NV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sensitivity and specificity of EMG and SSEP (if available) testing in identifying neural injury.
Time Frame: 8 weeks
For evaluation of the primary endpoint and additional assessments, descriptive statistics including mean, standard deviation, minimum, median, and maximum for continuous variables and frequency distribution for categorical variables will be provided, as well as tabular listings. All complications will be itemized including incidence, duration, and relationship to devices used and/or procedures performed.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Kelli Howell, MS, NuVasive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (Estimate)

December 26, 2011

Study Record Updates

Last Update Posted (Estimate)

July 15, 2014

Last Update Submitted That Met QC Criteria

July 14, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • NUVA.NV1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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