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CompletedNCT01499680NV in XLIF®Updated Dec 24, 2025

Multimodality Neuromonitoring in XLIF

An observational study in Degeneration of Lumbar Intervertebral Disc, sponsored by NuVasive. Completed at 20 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by NuVasive · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
323
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Degeneration of Lumbar Intervertebral Disc

Keywords

  • Degenerative Lumbar Conditions
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In context

Lead sponsor

NuVasive is the lead sponsor of 38 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Study population will consist of patients from participating site locations.

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
323 participants (actual)

Groups and cohorts

  • NV in XLIF

    This group will have the XLIF procedure done using NV.

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What researchers measure

Primary outcomes

  1. The sensitivity and specificity of EMG and SSEP (if available) testing in identifying neural injury.

    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.

    Time frame: 8 weeks

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01499680
Lead sponsor
NuVasive
Responsible party
Sponsor
First posted
Dec 26, 2011
Start date
Oct 2011
Primary completion
Dec 2013
Completion
Jun 2014
Last update
Dec 24, 2025

Study contacts

Kelli Howell, MS
study director · NuVasive

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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