RECRUITING

Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure

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Conditions

Intervertebral Disc DegenerationStenosis, SpinalSpondylolisthesisSpinal DeformitySpinal InstabilitySpineSurgeryAdultNeuromonitoringElectromyographySomatosensory evoked potentials

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-07-13
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05648474

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years of age at the time of planned surgery.
  2. * Indicated for 1- or 2-level instrumented LLIF surgery (in either prone or lateral decubitus positions), inclusive of the L4-5 disc space.
  3. * Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
  1. * Patients requiring surgical treatment at more than 2 lumbar levels.
  2. * Patients with peripheral neuropathy such as from diabetes or other conditions that might affect the reliability of intraoperative neuromonitoring.
  3. * 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.
  4. * 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.
  5. * Female patients who are pregnant or wanting to become pregnant during the timeframe of study participation.
  6. * Patients participating in another clinical study which may compromise this study's results or compliance with this study's procedures.

Contacts and Locations

Study Locations (Sites)

Alphatec Spine Inc.
Carlsbad, California, 92008
United States

Collaborators and Investigators

Sponsor: Alphatec Spine, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-13
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-07-13
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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