Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure

Part of paid clinical trials in Carlsbad, California.

Sponsor
Alphatec Spine, Inc.
Study ID
NCT05648474
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Somatosensory evoked potential [SSEP] intraoperative monitoring — DIAGNOSTIC_TEST
    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

Study Details

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.

Key Dates

Start date
Jul 13, 2022
Status verified
Oct 2024
Primary completion
Aug 28, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Adult undergoing 1- or 2-level lateral lumbar interbody fusion surgery, inclusive of the L4-5 level

Primary Outcome Measure

Sensitivity and specificity of SSEP neuromonitoring in post-operative clinical diagnosis of motor/sensory deficits [ Time Frame: 6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Alphatec Spine Inc.CarlsbadCalifornia92008
Saba Pasha, PhD
[email protected]
7603566639

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By research site
Alphatec Spine Inc.· Carlsbad, CA

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