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

Sponsor

Alphatec Spine, Inc.

Enrollment

400 participants

Start Date

Jul 13, 2022

Study Type

OBSERVATIONAL

Conditions

Intervertebral disc degeneration Spondylolisthesis Spinal Instability Spinal Deformity Stenosis, Spinal

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

At least 18 years of age at the time of planned surgery.
Indicated for 1- or 2-level instrumented LLIF surgery (in either prone or lateral decubitus positions), inclusive of the L4-5 disc space.
Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria6

Patients requiring surgical treatment at more than 2 lumbar levels.
Patients with peripheral neuropathy such as from diabetes or other conditions that might affect the reliability of intraoperative neuromonitoring.
Patients with prior history of partial/full hip or knee joint replacement surgery (i.e., arthroplasty or resurfacing) on the leg targeted for saphenous monitoring and electrode placement.
Patients with presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Female patients who are pregnant or wanting to become pregnant during the timeframe of study participation.
Patients participating in another clinical study which may compromise this study's results or compliance with this study's procedures.

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Interventions

DIAGNOSTIC_TESTSomatosensory 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