Advanced XLIF Monitoring Multicenter Study

Completed

Conditions studied: Degenerative Lumbar Disc Disease

In brief

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.

Key facts

Study ID

NCT02272140

Run by

NuVasive

People needed

324

Starts

2014-07-09

Expected to finish

2017-10-01

Last updated by the study team

2025-12-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Scripps Clinical Research Services — La Jolla, California, United States
• USF Neurology and Neurosurgery — Tampa, Florida, United States
• Foundation for Orthopaedic Research and Education (FORE) — Tampa, Florida, United States
• Piedmont Healthcare — Atlanta, Georgia, United States
• West Augusta Spine Specialists, LLC — Augusta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Columbia Orthopedic Group Research — Columbia, Missouri, United States
• Western Regional Center for Brain & Spine Surgery — Las Vegas, Nevada, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Seton Brain and Spine Institute — Austin, Texas, United States
• Northwest Orthopaedic Specialists, P.S. — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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