Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure

NCT05648474 | Recruiting FDA Device

• 1 other identifier: ATEC.AI-2001
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Intervertebral Disc Degeneration; Stenosis, Spinal; Spondylolisthesis; Spinal Deformity; Spinal Instability

Keywords

Spine; Surgery; Adult; Neuromonitoring; Electromyography; Somatosensory evoked potentials

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

Somatosensory evoked potential [SSEP] intraoperative monitoring DIAGNOSTIC_TEST

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

Adult undergoing 1- or 2-level lateral lumbar interbody fusion surgery, inclusive of the L4-5 level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alphatec Spine, Inc.: lead

Study Sites (1)

Alphatec Spine Inc.

Carlsbad, California, 92008, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis

Interventions

Evoked Potentials, Somatosensory; Monitoring, Intraoperative

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Intervention Hierarchy (Ancestors)

Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: July 13, 2022
• Primary Completion: August 28, 2025
• Study Completion: December 31, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

US (1)