- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01499680
Multimodality Neuromonitoring in XLIF (NV in XLIF®)
Multimodality Neuromonitoring In eXtreme Lateral Interbody Fusion (XLIF®)
Study Overview
Status
Conditions
Detailed Description
Subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will undergo neuromonitoring during the XLIF operation, as per standard care. They will then be re-evaluated immediately after surgery and at the first standard postoperative follow-up visit (6 weeks) to assess for presence of new neural deficit. If a new neural deficit is identified, the patient will be followed per the Investigator's standard follow-up schedule until symptoms have resolved (or are deemed permanent).
A total of 300 subjects will be enrolled in this study from multiple centers. The subjects will have degenerative conditions of the lumbar spine with planned treatment including XLIF surgery. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol is considered appropriate. All subjects must meet the inclusion/exclusion criteria below in order to be considered for enrollment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 00901
- Caribbean Orthopaedic and Spine Institute
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St. Gallen, Switzerland, 9007
- Kantonsspital St. Gallen
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California
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La Jolla, California, United States, 92037
- Shiley Center for Orthopaedic Research
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Orange, California, United States, 92868
- UC Irvine Medical Center
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Colorado
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Durango, Colorado, United States, 81301
- Durango Orthopaedics
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Florida
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Tampa, Florida, United States, 33606
- USF Neurology and Neurosurgery
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Georgia
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Augusta, Georgia, United States, 30909
- West Augusta Spine Specialists
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Decatur, Georgia, United States, 30033
- Georgia Spine and Neurosurgery Center
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Marietta, Georgia, United States, 30060
- Pinnacle Orthopaedics and Sports Medicine
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Illinois
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Bloomington, Illinois, United States, 61704
- McLean Country Orthopedics
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Peoria, Illinois, United States, 61605
- Illinois Neurological Institute
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Missouri
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Columbia, Missouri, United States, 65205
- Columbia Orthopaedic Group
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Jefferson City, Missouri, United States, 65101
- Spine Midwest, Inc.
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Nevada
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Las Vegas, Nevada, United States, 89109
- Western Regional Center for Brain and Spine Surgery
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Oregon
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Medford, Oregon, United States, 97504
- South Oregon Spine Care
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, United States, 15213
- Univerisity of Pittsburgh Medical Center
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South Carolina
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Conway, South Carolina, United States, 29526
- Coastal Orthopaedic Associates
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Texas
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San Antonio, Texas, United States, 78229
- Spine Pain Be Gone Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless surgical treatment is clinically indicated earlier
- Indicated for extreme lateral interbody fusion at any number of levels inclusive of L4-5
- At least 18 years of age at the date of written informed consent
- Able to undergo surgery based on physical exam, medical history and surgeon judgment
- Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
- Signed and dated informed consent form
Exclusion Criteria:
- Patient has a mental or physical condition that would limit the ability to comply with study requirements
- Patient is a prisoner
- Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
- Patient has an 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)
- Patient is participating in another clinical study that would confound study data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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NV in XLIF
This group will have the XLIF procedure done using NV.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The sensitivity and specificity of EMG and SSEP (if available) testing in identifying neural injury.
Time Frame: 8 weeks
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For evaluation of the primary endpoint and additional assessments, descriptive statistics including mean, standard deviation, minimum, median, and maximum for continuous variables and frequency distribution for categorical variables will be provided, as well as tabular listings.
All complications will be itemized including incidence, duration, and relationship to devices used and/or procedures performed.
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kelli Howell, MS, NuVasive
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUVA.NV1001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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