NCT01499680

Multimodality Neuromonitoring in XLIF

Multimodality Neuromonitoring In eXtreme Lateral Interbody Fusion (XLIF®)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 323 (actual)
• Sponsor: NuVasive · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will undergo neuromonitoring during the XLIF operation, as per standard care. They will then be re-evaluated immediately after surgery and at the first standard postoperative follow-up visit (6 weeks) to assess for presence of new neural deficit. If a new neural deficit is identified, the patient will be followed per the Investigator's standard follow-up schedule until symptoms have resolved (or are deemed permanent). A total of 300 subjects will be enrolled in this study from multiple centers. The subjects will have degenerative conditions of the lumbar spine with planned treatment including XLIF surgery. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol is considered appropriate. All subjects must meet the inclusion/exclusion criteria below in order to be considered for enrollment.

Conditions

• Degeneration of Lumbar Intervertebral Disc

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-12-01
• Completion: 2014-06-01
• First posted: 2011-12-26
• Last updated: 2025-12-24

Locations

20 sites across 3 countries: United States, Puerto Rico, Switzerland