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Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure

NCT05648474 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-10-24

No results posted yet for this study

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

  • Intervertebral Disc Degeneration
  • Stenosis, Spinal
  • Spondylolisthesis
  • Spinal Deformity
  • Spinal Instability

Interventions

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

Sponsors & Collaborators

  • Alphatec Spine, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-13
Primary Completion
2025-08-28
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05648474 on ClinicalTrials.gov