Advanced XLIF Monitoring Multicenter Study

NCT02272140 | Completed

• 1 other identifier: NUVA.NV1401
• Study Type: observational
• Target: 324
• Locations: 1 country
• Sites: 12

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.

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

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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:

• 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.

Sponsors & Collaborators

• NuVasive: lead

Study Sites (12)

Scripps Clinical Research Services

La Jolla, California, 92037, United States

Location

USF Neurology and Neurosurgery

Tampa, Florida, 33606, United States

Location

Foundation for Orthopaedic Research and Education (FORE)

Tampa, Florida, 33637, United States

Location

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

Location

West Augusta Spine Specialists, LLC

Augusta, Georgia, 30909, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Columbia Orthopedic Group Research

Columbia, Missouri, 65201, United States

Location

Western Regional Center for Brain & Spine Surgery

Las Vegas, Nevada, 89109, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Seton Brain and Spine Institute

Austin, Texas, 78701, United States

Location

Northwest Orthopaedic Specialists, P.S.

Spokane, Washington, 99208, United States

Location

Study Officials

• Kyle Malone, MS

  NuVasive

  STUDY DIRECTOR

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
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)