Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure

Recruiting

• Conditions: Spondylolisthesis; Stenosis, Spinal; Spinal Deformity; Spinal Instability; Intervertebral Disc Degeneration
• Interventions: Diagnostic Test: Somatosensory evoked potential [SSEP] intraoperative monitoring

• Registration Number: NCT05648474
• Lead Sponsor: Alphatec Spine, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-13
• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2025-08-28
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult undergoing 1- or 2-level lateral lumbar interbody fusion surgery, inclusive of the L4-5 level	Somatosensory evoked potential [SSEP] intraoperative monitoring	-

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of SSEP neuromonitoring in post-operative clinical diagnosis of motor/sensory deficits	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 Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Alphatec Spine Inc.; 🇺🇸 Carlsbad, California, United States