Trials / Recruiting
RecruitingNCT05648474
Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
Advanced Techniques in Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure: a Utility Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (estimated)
- Sponsor
- Alphatec Spine, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk during the lateral lumbar interbody fusion (LLIF) procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Somatosensory evoked potential [SSEP] intraoperative monitoring | No study specific intervention is performed. Intraoperative neuromonitoring system that is observed in this study is for assessing the health of the lumbar plexus during lateral lumbar interbody fusion surgery |
Timeline
- Start date
- 2022-07-13
- Primary completion
- 2025-08-28
- Completion
- 2025-12-31
- First posted
- 2022-12-13
- Last updated
- 2024-10-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05648474. Inclusion in this directory is not an endorsement.