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Observational Study of Intraoperative Monitoring for Lateral Lumbar Interbody Fusion

This study is looking at how well a monitoring system, called Somatosensory Evoked Potential (SSEP), works during a back surgery called lateral lumbar interbody fusion (LLIF). SSEP monitoring helps doctors check the health of nerves in your lower back during surgery. The study aims to see how accurately SSEP can detect nerve changes that might lead to problems after surgery. You may be able to join if you are at least 18 years old and are having 1- or 2-level LLIF surgery. The study will be successful if SSEP monitoring can reliably identify nerve issues after surgery. The current recruitment status is unclear, and the study plans to enroll 400 participants.

Study design
This is an observational study, meaning researchers will watch and collect information during your surgery. It plans to include 400 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 weeks, or until any new or worsened nerve problems resolve, but no longer than 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05648474

Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure

Recruiting
Not specifiedAges 18+Observational
Alphatec Spine, Inc.
~400 participants
Updated 2024-10-24 on ClinicalTrials.gov
What's tested:Somatosensory evoked potential [SSEP] intraoperative monitoring

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity and specificity of SSEP neuromonitoring in post-operative clinical diagnosis of motor/sensory deficits
Measured over 6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months.

Conditions

Intervertebral Disc Degeneration
Stenosis, Spinal
Spondylolisthesis
Spinal Deformity
Spinal Instability

Explore related trials

Intervertebral Disc Degenerative DisorderSpinal DeformitySpinal instabilitySpinal StenosisSpondylolisthesis

Where it's being run

1 sites across 1 states
California1

Who to contact

Saba Pasha, PhD
[email protected]
7603566639
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Sensitivity and specificity of SSEP neuromonitoring in post-operative clinical diagnosis of motor/sensory deficits6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months.

    This outcome measure determines the utility of the saphenous nerve SSEP monitoring based on the correlation of intraoperative neuromonitoring results with new or worsened postoperative neural deficits, as measured by motor and sensory physical exam.