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RECRUITING

Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure

Advanced Techniques in Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure: a Utility Study

NCT05648474•Alphatec Spine, Inc.

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.

Locations (1)

Alphatec Spine Inc.

Carlsbad, California, United States

Key Dates

Start Date

July 13, 2022

Primary Completion Date

August 28, 2025

Completion Date

December 31, 2025

Last Updated

October 24, 2024

Enrollment

400

ESTIMATED participants

Conditions

Intervertebral Disc DegenerationStenosis, SpinalSpondylolisthesisSpinal DeformitySpinal Instability

Interventions

Somatosensory evoked potential [SSEP] intraoperative monitoring

DIAGNOSTIC_TEST

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

NCT05029726

Lumbar Spinal StenosisLumbar Disc Herniation+8 more

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RECRUITINGNA

Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)

NCT06129682

Spondylolisthesis, Lumbar Region

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure

Inclusion Criteria

Exclusion Criteria

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)

PREventing Pain After Surgery

Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis

Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

Open Access Database of Standing Full Body Radiographs in Asymptomatic Volunteers