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Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
RecruitingObservational study
Advanced Techniques in Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure: a Utility Study
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Somatosensory evoked potential [SSEP] intraoperative monitoring (diagnostic test)
Sponsor: Alphatec Spine, Inc. · Participants: 400 · Started: Jul 13, 2022
Contact the study team
Official record on ClinicalTrials.gov — NCT05648474
Locations in the U.S.
| California | Alphatec Spine Inc., Carlsbad |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.