Multimodality Neuromonitoring in XLIF
Completed
Conditions studied: Degeneration of Lumbar Intervertebral Disc
In brief
This is a prospective, non-randomized multi-center study to evaluate intraoperative neuromonitoring results in subjects who undergo eXtreme Lateral Interbody Fusion (XLIF) surgery at any number of levels inclusive of L4-5.
Key facts
- Study ID
- NCT01499680
- Run by
- NuVasive
- People needed
- 323
- Starts
- 2011-10-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2025-12-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Shiley Center for Orthopaedic Research — La Jolla, California, United States
- UC Irvine Medical Center — Orange, California, United States
- Durango Orthopaedics — Durango, Colorado, United States
- USF Neurology and Neurosurgery — Tampa, Florida, United States
- West Augusta Spine Specialists — Augusta, Georgia, United States
- Georgia Spine and Neurosurgery Center — Decatur, Georgia, United States
- Pinnacle Orthopaedics and Sports Medicine — Marietta, Georgia, United States
- McLean Country Orthopedics — Bloomington, Illinois, United States
- Illinois Neurological Institute — Peoria, Illinois, United States
- Columbia Orthopaedic Group — Columbia, Missouri, United States
- Spine Midwest, Inc. — Jefferson City, Missouri, United States
- Western Regional Center for Brain and Spine Surgery — Las Vegas, Nevada, United States
- Duke University Medical Center — Durham, North Carolina, United States
- South Oregon Spine Care — Medford, Oregon, United States
- Univerisity of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- Coastal Orthopaedic Associates — Conway, South Carolina, United States
- Spine Pain Be Gone Clinic — San Antonio, Texas, United States
- Caribbean Orthopaedic and Spine Institute — San Juan, PR, Puerto Rico
- Kantonsspital St. Gallen — Sankt Gallen, Switzerland
Full record on ClinicalTrials.gov
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