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Clinical Trials in the USA / NCT05648474
Recruiting Observational

Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure

NCT05648474 · tracked via the Priya Life Science USA tracker
Sponsor
Alphatec Spine, Inc.
Phase
Observational
Started
2022-07-13
Last updated
2024-10-24

Condition(s) studied

Intervertebral Disc DegenerationStenosis, SpinalSpondylolisthesisSpinal DeformitySpinal Instability

Investigational drug(s) / intervention(s)

Somatosensory evoked potential [SSEP] intraoperative monitoring

Somatosensory evoked potential [SSEP] intraoperative monitoring: 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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Alphatec Spine Inc. Carlsbad California Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05648474 on ClinicalTrials.gov ↗ ← All trials in the USA