Status:
COMPLETED
Multimodality Neuromonitoring in XLIF
Lead Sponsor:
NuVasive
Conditions:
Degeneration of Lumbar Intervertebral Disc
Eligibility:
All Genders
18+ years
Brief Summary
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 lev...
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 dur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT01499680
Start Date
October 1 2011
End Date
June 1 2014
Last Update
December 24 2025
Active Locations (20)
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1
Shiley Center for Orthopaedic Research
La Jolla, California, United States, 92037
2
UC Irvine Medical Center
Orange, California, United States, 92868
3
Durango Orthopaedics
Durango, Colorado, United States, 81301
4
USF Neurology and Neurosurgery
Tampa, Florida, United States, 33606