Multimodality Neuromonitoring in eXtreme Lateral Interbody Fusion (XLIF)

Trial ID:
IRB-12-5867
Robert Eastlack
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.

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

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