Multimodality Neuromonitoring in XLIF (NCT01499680) | Clinical Trial Compass
CompletedNot Applicable
Multimodality Neuromonitoring in XLIF
United States323 participantsStarted 2011-10
Plain-language 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 levels inclusive of L4-5.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
The sensitivity and specificity of EMG and SSEP (if available) testing in identifying neural injury.