Status:
COMPLETED
Advanced XLIF Monitoring Multicenter Study
Lead Sponsor:
NuVasive
Conditions:
Degenerative Lumbar Disc Disease
Eligibility:
All Genders
18-80 years
Brief Summary
The objective of this study is to evaluate the utility of localized stimulation of the lumbosacral nerve roots during XLIF through correlation of observed changes in the response latency, amplitude, w...
Detailed Description
The utility of NVM5 neuromonitoring by stimulating within the surgical site during XLIF has been previously demonstrated; however, it is possible that depending on the site of injury, this method of m...
Eligibility Criteria
Inclusion
- Male and female spine surgery patients who are at least 18 years of age;
- Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless surgical treatment is clinically indicated earlier;
- Surgical candidates for extreme lateral approach lumbar spine surgery at spinal levels L2 to L5, inclusive of L4-5;
- Able to undergo surgery based on physical exam, medical history and surgeon judgment;
- Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation.
Exclusion
- Patient has a mental or physical condition that would limit the ability to comply with study requirements;
- Currently undergoing any surgical treatment at any spinal level other than L2 to L5;
- Currently undergoing surgical treatment for significant deformity correction (e.g., osteotomy, anterior longitudinal ligament release, or other significant manipulation of the spinal column);
- 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);
- 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);
- Pregnant women;
- Patient is a prisoner;
- Patient is participating in another clinical study that would confound study data.
Key Trial Info
Start Date :
July 9 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT02272140
Start Date
July 9 2014
End Date
October 1 2017
Last Update
December 22 2025
Active Locations (12)
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1
Scripps Clinical Research Services
La Jolla, California, United States, 92037
2
USF Neurology and Neurosurgery
Tampa, Florida, United States, 33606
3
Foundation for Orthopaedic Research and Education (FORE)
Tampa, Florida, United States, 33637
4
Piedmont Healthcare
Atlanta, Georgia, United States, 30309