Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure

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

Study Overview

• Status: Recruiting
• Conditions: Intervertebral Disc Degeneration; Spondylolisthesis; Spinal Deformity; Stenosis, Spinal; Spinal Instability
• Intervention / Treatment: Diagnostic test: Somatosensory evoked potential [SSEP] intraoperative monitoring

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• United States
  • California
    • Carlsbad, California, United States, 92008
      • Recruiting
      • Alphatec Spine Inc.
      • Contact: Saba Pasha, PhD; Phone Number: 7603566639; Email: spasha@atecspine.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients of both sexes undergoing LLIF surgery atone or two levels inclusive of the L4-5 level.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult undergoing 1- or 2-level lateral lumbar interbody fusion surgery, inclusive of the L4-5 level	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of SSEP neuromonitoring in post-operative clinical diagnosis of motor/sensory deficits	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.	6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the positive predictive value (PPV) and negative predictive value (NPV) of free run and SSEP monitoring modalities.	This outcome measure includes: Correlating specific monitoring findings with incidence of new or worsened motor or sensory deficits post-operatively and their correlation with patient-specific and surgical factors.; Correlating patient and surgical factors with new and worsened postoperative neural deficits.	6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months.

Collaborators and Investigators

• Sponsor: Alphatec Spine, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Estimated): August 28, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Adult; Electromyography; Spine; Neuromonitoring; Somatosensory evoked potentials
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spondylolysis; Spondylosis; Spinal Stenosis; Spondylolisthesis; Intervertebral Disc Degeneration
• Other Study ID Numbers: ATEC.AI-2001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No