Actively Recruiting
Advanced Techniques in Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure: a Utility Study
Led by Alphatec Spine, Inc. · Updated on 2024-10-24
400
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of somatosensory evoked potential (SSEP) intraoperative monitoring during the lateral lumbar interbody fusion (LLIF) procedure. The study aims to assess how well this known monitoring method, using the saphenous nerve for stimulation, can detect changes in lumbar nerves at risk during surgery. The goal is to understand the clinical usefulness of SSEP in identifying nerve issues that might arise during LLIF. The study involves adult participants undergoing 1- or 2-level LLIF surgery, including the L4-5 disc space. No additional interventions are performed beyond standard intraoperative neuromonitoring, which observes lumbar plexus health during the surgery. This is an observational study where the SSEP monitoring system is used to collect data without altering usual surgical care. Participants will be followed for up to 12 months after surgery, with assessments focused on detecting motor or sensory deficits that may develop. Researchers measure the sensitivity and specificity of SSEP monitoring in diagnosing postoperative nerve problems. Secondary outcomes include predictive values of SSEP and free run monitoring. The study involves clinical evaluations and monitoring of neurological function during the follow-up period to understand the monitoring's accuracy and usefulness.
CONDITIONS
Brief 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, including the L4-5 disc space.
- Able and willing to provide written informed consent and comply with study requirements.
You will not qualify if you...
- Need for surgery at more than 2 lumbar levels.
- Presence of peripheral neuropathy such as from diabetes or other causes.
- Prior partial or full hip or knee joint replacement on the leg targeted for saphenous nerve monitoring.
- Any condition that could compromise patient safety or data quality as per Investigator’s opinion.
- Female patients who are pregnant or planning pregnancy during the study period.
- Participation in another clinical study that may interfere with this study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants undergo intraoperative neuromonitoring during lateral lumbar interbody fusion surgery to assess the health of the lumbar plexus.
1 visit (in-person on surgery day)
Duration - Up to 12 months
Participants are monitored for up to 12 months after surgery to evaluate motor and sensory function recovery and the accuracy of neuromonitoring.
Follow-up visits as needed up to 12 months
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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