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NCT02272140 · ClinicalTrials.gov registry record
Advanced XLIF Monitoring Multicenter Study
A clinical trial of Degenerative Lumbar Disc Disease, sponsored by NuVasive.
- Completed
- Registry status
- 324
- Enrollment target
- 12
- Study locations
NCT02272140: Completed study of Degenerative Lumbar Disc Disease, sponsored by NuVasive.
NCT02272140 is a study of Degenerative Lumbar Disc Disease that has completed, run by NuVasive. The registered enrollment target is 324 participants. The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02272140, a study of Degenerative Lumbar Disc Disease, has completed, sponsored by NuVasive.
- COMPLETED
- Registry status
- 324 participants
- Enrollment target
- 12
- Study locations
Study 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, waveform morphology, and/or response threshold with surgical events. Additionally, correlation between neuromonitoring findings and postoperative neural status will be evaluated.
Primary Outcome
Intraoperative neuromonitoring findings will be correlated with postoperative neural status up to six weeks post-op to determine the sensitivity and specificity of this testing modality's ability to detect postoperative decreases in motor function during the XLIF procedure.
Conditions Studied
Study Locations (12)
Florida
- USF Neurology and Neurosurgery - Tampa
- Foundation for Orthopaedic Research and Education (FORE) - Tampa
Georgia
- Piedmont Healthcare - Atlanta
- West Augusta Spine Specialists, LLC - Augusta
California
- Scripps Clinical Research Services - La Jolla
Massachusetts
- Massachusetts General Hospital - Boston
Missouri
- Columbia Orthopedic Group Research - Columbia
Nevada
- Western Regional Center for Brain & Spine Surgery - Las Vegas
North Carolina
- Duke University Medical Center - Durham
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2014-07-09 |
| Est. Completion | 2017-10 |
What the finished NCT02272140 record still lists
NCT02272140 is an observational study that tracks outcomes without assigning an intervention. The registered 324 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Degenerative Lumbar Disc Disease appearing as the primary indexed condition, and to 0 interventions.
NCT02272140 lists 12 locations in 10 states (Florida, Georgia, California).
Frequently Asked Questions
What is clinical trial NCT02272140 about?
NCT02272140 is a clinical study titled "Advanced XLIF Monitoring Multicenter Study". 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, waveform morphology, and/or response threshold with surgical events. Additionally, correlation betwee...
What is the current status of trial NCT02272140?
This trial is currently completed. The enrollment target is 324 participants. The study started on 2014-07-09. Estimated completion is 2017-10.
What conditions does trial NCT02272140 study?
This clinical trial studies the following conditions: Degenerative Lumbar Disc Disease.
Who is sponsoring clinical trial NCT02272140?
This trial is sponsored by NuVasive, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02272140 being conducted?
This trial has 12 study locations across California, Florida, Georgia, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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