Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Somatosensory evoked potential [SSEP] intraoperative monitoring.
- Who it may be relevant to
- Registry conditions: Intervertebral Disc Degeneration, Stenosis, Spinal, Spondylolisthesis, Spinal Deformity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Advanced Techniques in Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure: a Utility Study
Overview
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.
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
Primary outcome measures
- 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.]
Secondary outcome measures (1)
- Determination of the positive predictive value (PPV) and negative predictive value (NPV) of free run and SSEP monitoring modalities. [Time frame: 6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Alphatec Spine Inc. — Carlsbad
Identifiers
NCT: NCT05648474 · ATEC.AI-2001