Advanced XLIF Monitoring Multicenter Study

NCT ID: NCT02272140

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 324 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-09
• Study Completion Date: 2017-10-31

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.

Detailed Description

The utility of NVM5 neuromonitoring by stimulating within the surgical site during XLIF has been previously demonstrated; however, it is possible that depending on the site of injury, this method of monitoring may stimulate nerves at a location that is distal to the site of injury along the nerve conduction pathway. In this example, the site of injury would not disrupt the stimulus and a normal muscle response may occur, providing a false negative result. With this in mind, it has been hypothesized that more accurate information may be gathered by stimulating the lumbar roots or spinal nerves cranial to the surgical site and recording the subsequent muscle response in the lower limbs. Using this technique, the response to the stimulus would traverse the surgical site, including the site of any nerve injury. Currently, the only described method of stimulating cranial to the surgical site is with transcranial motor evoked potentials (tcMEP); stimulating the lumbosacral nerve roots locally has not been demonstrated. Though tcMEP monitoring is a well-documented technique, there are several limitations associated with its use. For example, tcMEP requires adherence to total intravenous anesthesia (TIVA), thereby restricting the use of inhalational agents. This restriction may require additional training and coordination with the anesthesiologist, as well as added cost to the hospital.6 Additional challenges with tcMEP include the requirements for high voltage stimulation to successfully transmit a stimulus across the skull. In rare instances this can cause seizures, tongue lacerations, and other complications. Finally, due to inclusion of the central nervous system, monitoring with tcMEP may be less reproducible and specific than a more localized stimulation.

To address these challenges, recent adaptations to standard MEP and EMG monitoring protocols have used local stimulation of the lumbosacral nerve roots at the level of the conus, with recorded responses from the relevant innervated muscle groups of the lower limbs. Early experience using this technique has shown the feasibility and reproducibility of obtaining reliable baseline and longitudinal responses throughout a surgical procedure, and incorporation of this monitoring modality has become common practice at certain surgical sites performing XLIF, although determination of clinically meaningful changes in those responses have yet to be determined.

Conditions

Degenerative Lumbar Disc Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

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

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

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

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

Exclusion Criteria

1. Patient has a mental or physical condition that would limit the ability to comply with study requirements;

2. Currently undergoing any surgical treatment at any spinal level other than L2 to L5;

3. Currently undergoing surgical treatment for significant deformity correction (e.g., osteotomy, anterior longitudinal ligament release, or other significant manipulation of the spinal column);

4. 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);

5. Implanted pacemaker, defibrillator, or other electronic devices;

6. Involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested);

7. Pregnant women;

8. Patient is a prisoner;

9. Patient is participating in another clinical study that would confound study data.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NuVasive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyle Malone, MS

Role: STUDY_DIRECTOR

NuVasive

Locations

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

Countries

United States

Other Identifiers

NUVA.NV1401

Identifier Type: -

Identifier Source: org_study_id