Status:
COMPLETED
Advanced XLIF Monitoring Pilot Study
Lead Sponsor:
NuVasive
Conditions:
Degenerative Lumbar Disc Disease
Eligibility:
All Genders
18+ years
Brief Summary
Though the utility of NVM5 neuromonitoring by stimulating within the surgical site during XLIF has been demonstrated, it is hypothesized that more information may be gathered if a greater section of t...
Eligibility Criteria
Inclusion
- Male and female spine surgery patients who are at least 18 years of age
- Surgical candidates for lateral approach lumbar spine surgery at spinal levels L2 to L5, inclusive of L4-5
- Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation
Exclusion
- Currently undergoing surgical treatment at any spinal level other than L2 to L5, including S1
- Pregnant women
- Implanted pacemaker, defibrillator, or other electronic devices
- Involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
- 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)
Key Trial Info
Start Date :
June 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 8 2018
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT02192112
Start Date
June 1 2014
End Date
May 8 2018
Last Update
December 22 2025
Active Locations (2)
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1
Durango Orthopaedics Associates/Spine Colorado
Durango, Colorado, United States, 81301
2
Pinnacle Orthopaedics & Sports Medicine Specialists
Marrietta, Georgia, United States, 30060