NCT02272140

Completed

Advanced XLIF Monitoring Multicenter Study

NuVasive Source

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Other study identifiers

Sponsor study identifier

NUVA.NV1401

Study Type

observational

Actual enrollment (reported)

324

Locations

1 country

Sites

12

Timeline

Study Start

July 9, 2014

Actual (reported)

Primary Completion

October 2017

Actual (reported)

Study Completion

October 2017

Actual (reported)

Brief Summary

The objective of this study is to evaluate the utility of localized stimulation of the lumbosacral nerve roots during XLIF through correlation of observed changes in the response latency, amplitude, waveform morphology, and/or response threshold with surgical events. Additionally, correlation between neuromonitoring findings and postoperative neural status will be evaluated.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 324 participants
Study completion date: October 2017
Actual (reported)
Listed locations: 1 countries · 12 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 9, 2014
Actual (reported)
First Submitted
October 17, 2014
Actual (reported)
First Posted
October 22, 2014
Actual (reported)
Primary Completion
October 2017
Actual (reported)
Study Completion
October 2017
Actual (reported)

Last Updated: December 22, 2025
Status Verified: December 2025
Last Update Submitted: December 16, 2025

Conditions

Degenerative Lumbar Disc Disease

Outcome Measures

Primary Outcomes (1)

Sensitivity and specificity of this neuromonitoring technique in identifying neural injury after the XLIF procedure.
Intraoperative neuromonitoring findings will be correlated with postoperative neural status up to six weeks post-op to determine the sensitivity and specificity of this testing modality's ability to detect postoperative decreases in motor function during the XLIF procedure.
6 weeks

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients who, in the investigator's opinion, require lateral approach spinal fusion surgery at spinal level L4-5 (though may include any number of levels from L2 through L5), and have consented to XLIF surgery for their condition will be included. All subjects must meet the inclusion/exclusion criteria below in order to be considered for enrollment.

You may qualify if:

Sponsors & Collaborators

NuVasive
Industrylead

Study Sites (12)

Scripps Clinical Research Services

La Jolla, California, 92037, United States

USF Neurology and Neurosurgery

Tampa, Florida, 33606, United States

Foundation for Orthopaedic Research and Education (FORE)

Tampa, Florida, 33637, United States

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

West Augusta Spine Specialists, LLC

Augusta, Georgia, 30909, United States

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Columbia Orthopedic Group Research

Columbia, Missouri, 65201, United States

Study Officials

Kyle Malone, MS
NuVasive
STUDY DIRECTOR

Enrollment

324 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 17, 2014

First Posted

October 22, 2014

Study Start

July 9, 2014

Actual (reported)

Male and female spine surgery patients who are at least 18 years of age;

Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless surgical treatment is clinically indicated earlier;

Surgical candidates for extreme lateral approach lumbar spine surgery at spinal levels L2 to L5, inclusive of L4-5;

Able to undergo surgery based on physical exam, medical history and surgeon judgment;

Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation.

You may not qualify if:

Patient has a mental or physical condition that would limit the ability to comply with study requirements;
Currently undergoing any surgical treatment at any spinal level other than L2 to L5;
Currently undergoing surgical treatment for significant deformity correction (e.g., osteotomy, anterior longitudinal ligament release, or other significant manipulation of the spinal column);
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);
Implanted pacemaker, defibrillator, or other electronic devices;
Involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested);
Pregnant women;
Patient is a prisoner;
Patient is participating in another clinical study that would confound study data.

Contact the study team to confirm eligibility.

Western Regional Center for Brain & Spine Surgery

Las Vegas, Nevada, 89109, United States

Duke University Medical Center

Durham, North Carolina, 27710, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Seton Brain and Spine Institute

Austin, Texas, 78701, United States

Northwest Orthopaedic Specialists, P.S.

Spokane, Washington, 99208, United States

Primary Completion

October 2017

Actual (reported)

Study Completion

October 2017

Actual (reported)

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02272140
Data provider: ClinicalTrials.gov
Source updated: 2025-12-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:52 UTC

Locations

US(12)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (12)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations