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NCT Number: NCT05648474

Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure

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.

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Key information

Conditions

Intervertebral Disc Degeneration Bone Diseases Musculoskeletal Diseases Spinal Deformity Spinal Diseases Spinal Instability Spinal Stenosis Spondylolisthesis Spondylolysis Spondylosis Stenosis, Spinal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alphatec Spine Inc.

Carlsbad, California, 92008, United States

Location status: Recruiting

Location contact

Saba Pasha, PhD

CONTACT

[email protected]

7603566639

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  1. Determination of the positive predictive value (PPV) and negative predictive value (NPV) of free run and SSEP monitoring modalities.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alphatec Spine, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2022
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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