Actively Recruiting
Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
Led by Alphatec Spine, Inc. · Updated on 2024-10-24
400
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Alphatec Spine Inc.
Carlsbad, California, United States, 92008
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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