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Trial record 4 of 27 for:    Nuvasive

Advanced XLIF Monitoring Multicenter Study

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02272140
First Posted: October 22, 2014
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
NuVasive
  Purpose
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.

Condition
Degenerative Lumbar Disc Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by NuVasive:

Primary Outcome Measures:
  • Sensitivity and specificity of this neuromonitoring technique in identifying neural injury after the XLIF procedure. [ Time Frame: 6 weeks ]
    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.


Estimated Enrollment: 316
Study Start Date: October 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total of 316 subjects will be enrolled in this study from multiple centers. 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.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272140


Locations
United States, California
Scripps Clinical Research Services
La Jolla, California, United States, 92037
United States, Florida
USF Neurology and Neurosurgery
Tampa, Florida, United States, 33606
Foundation for Orthopaedic Research and Education (FORE)
Tampa, Florida, United States, 33637
United States, Georgia
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
West Augusta Spine Specialists, LLC
Augusta, Georgia, United States, 30909
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Missouri
Columbia Orthopedic Group Research
Columbia, Missouri, United States, 65201
United States, Nevada
Western Regional Center for Brain & Spine Surgery
Las Vegas, Nevada, United States, 89109
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Seton Brain and Spine Institute
Austin, Texas, United States, 78701
United States, Washington
Northwest Orthopaedic Specialists, P.S.
Spokane, Washington, United States, 99208
Sponsors and Collaborators
NuVasive
Investigators
Study Director: Kelli Howell, MS NuVasive
  More Information

Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT02272140     History of Changes
Other Study ID Numbers: NUVA.NV1401
First Submitted: October 17, 2014
First Posted: October 22, 2014
Last Update Posted: March 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No