Multimodality Neuromonitoring in XLIF

NCT01499680 | Completed

• 1 other identifier: NUVA.NV1001
• Study Type: observational
• Target: 323
• Locations: 3 countries
• Sites: 20

Brief 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.

Conditions

Degeneration of Lumbar Intervertebral Disc

Keywords

Degenerative Lumbar Conditions

Outcome Measures

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.

  8 weeks

Study Arms (1)

NV in XLIF

This group will have the XLIF procedure done using NV.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population will consist of patients from participating site locations.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NuVasive: lead

Study Sites (20)

Shiley Center for Orthopaedic Research

La Jolla, California, 92037, United States

Location

UC Irvine Medical Center

Orange, California, 92868, United States

Location

Durango Orthopaedics

Durango, Colorado, 81301, United States

Location

USF Neurology and Neurosurgery

Tampa, Florida, 33606, United States

Location

West Augusta Spine Specialists

Augusta, Georgia, 30909, United States

Location

Georgia Spine and Neurosurgery Center

Decatur, Georgia, 30033, United States

Location

Pinnacle Orthopaedics and Sports Medicine

Marietta, Georgia, 30060, United States

Location

McLean Country Orthopedics

Bloomington, Illinois, 61704, United States

Location

Illinois Neurological Institute

Peoria, Illinois, 61605, United States

Location

Columbia Orthopaedic Group

Columbia, Missouri, 65205, United States

Location

Spine Midwest, Inc.

Jefferson City, Missouri, 65101, United States

Location

Western Regional Center for Brain and Spine Surgery

Las Vegas, Nevada, 89109, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

South Oregon Spine Care

Medford, Oregon, 97504, United States

Location

Univerisity of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Coastal Orthopaedic Associates

Conway, South Carolina, 29526, United States

Location

Spine Pain Be Gone Clinic

San Antonio, Texas, 78229, United States

Location

Caribbean Orthopaedic and Spine Institute

San Juan, PR, 00901, Puerto Rico

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Study Officials

• Kelli Howell, MS

  NuVasive

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 26, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

CH (1); US (18); PR (1)