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

Alphatec Spine, Inc.1 site in 1 country400 target enrollmentJuly 13, 2022

ConditionsIntervertebral Disc Degeneration Stenosis, Spinal Spondylolisthesis Spinal Deformity Spinal Instability

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intervertebral Disc Degeneration
Sponsor: Alphatec Spine, Inc.
Enrollment: 400
Locations: 1
Primary Endpoint: Sensitivity and specificity of SSEP neuromonitoring in post-operative clinical diagnosis of motor/sensory deficits
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 13, 2022

End Date

December 31, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Alphatec Spine, Inc.

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

Determination of the positive predictive value (PPV) and negative predictive value (NPV) of free run and SSEP monitoring modalities.(6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months.)