Actively Recruiting
Advanced Intraoperative Monitoring Using SSEP for Lumbar Spine Fusion Surgery Including L4-5 Levels
Led by Alphatec Spine, Inc. · Updated on 2024-10-24
400
Participants Needed
1
Research Sites
17 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of somatosensory evoked potential SSEP intraoperative monitoring during the lateral lumbar interbody fusion LLIF procedure. The study aims to assess how well this known monitoring method, using the saphenous nerve for stimulation, can detect changes in lumbar nerves at risk during surgery. The goal is to understand the clinical usefulness of SSEP in identifying nerve issues that might arise during LLIF. The study involves adult participants undergoing 1- or 2-level LLIF surgery, including the L4-5 disc space. No additional interventions are performed beyond standard intraoperative neuromonitoring, which observes lumbar plexus health during the surgery. This is an observational study where the SSEP monitoring system is used to collect data without altering usual surgical care. Participants will be followed for up to 12 months after surgery, with assessments focused on detecting motor or sensory deficits that may develop. Researchers measure the sensitivity and specificity of SSEP monitoring in diagnosing postoperative nerve problems. Secondary outcomes include predictive values of SSEP and free run monitoring. The study involves clinical evaluations and monitoring of neurological function during the follow-up period to understand the monitorings accuracy and usefulness.
CONDITIONS
Brief Title
Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
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