Clinical trial NCT02272140: Advanced XLIF Monitoring Multicenter Study
Official title: A Prospective, Non-randomized, Multicenter Evaluation of the Utility of Transcutaneous Stimulation of the Lumbosacral Nerve Roots During XLIF® and Its Relationship to Postoperative Nerve Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Lumbar Disc Disease
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2014-10-22
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Sensitivity and specificity of this neuromonitoring technique in identifying neural injury after the XLIF procedure.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinical Research Services
state: California
city: Tampa
country: United States
facility: USF Neurology and Neurosurgery
state: Florida
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research and Education (FORE)
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Augusta
country: United States
facility: West Augusta Spine Specialists, LLC
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Columbia
country: United States
facility: Columbia Orthopedic Group Research
state: Missouri
city: Las Vegas
country: United States
facility: Western Regional Center for Brain & Spine Surgery
state: Nevada
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: Seton Brain and Spine Institute
state: Texas
city: Spokane
country: United States
facility: Northwest Orthopaedic Specialists, P.S.
state: Washington
Study officials:
affiliation: NuVasive
name: Kyle Malone, MS
role: STUDY_DIRECTOR
References: