Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure

Launched by ALPHATEC SPINE, INC. · Dec 5, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a specific technique called intraoperative neuromonitoring to help doctors during a surgery known as lateral lumbar interbody fusion (LLIF). This surgery is performed on patients with issues affecting the lower back, like disc degeneration or spinal instability. The goal of the study is to see if monitoring the saphenous nerve during the surgery can help detect any potential problems with the lumbar nerves, which could be at risk during the procedure.

To participate in this trial, you need to be at least 18 years old and scheduled for 1 or 2-level LLIF surgery involving the lower back. Unfortunately, if you have certain conditions like diabetes-related nerve damage, or if you've had joint replacement surgery on the leg that will be monitored, you won’t be eligible. Participants will be asked to give their written consent and follow the study's guidelines. If you join, you can expect to help researchers learn more about how to safely perform this type of surgery, which may improve outcomes for future patients.

Gender

ALL

Eligibility criteria

• 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.