Advanced Techniques in Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure: a Utility Study
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Alphatec Spine Inc.
RECRUITING
Carlsbad
Time Frame
Start Date: 2022-07-13
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 400
Treatments
Adult undergoing 1- or 2-level lateral lumbar interbody fusion surgery, inclusive of the L4-5 level
Related Therapeutic Areas
Sponsors
Leads: Alphatec Spine, Inc.