Intraoperative Monitoring: Lateral Lumbar Interbody Fusion Procedure

What is the Purpose of this Study?

The purpose of this study is to document the usefulness of an intraoperative neuromonitoring (IONM) system that is already established and approved by the U.S. Food and Drug Administration (FDA). The system is used to monitor nerve health during lateral lumbar interbody fusion (LLIF) surgical procedures. Specifically, the study will record the information that is provided by the neuromonitoring system to the patient’s surgeon and how that information was used. The study may provide information about how such monitoring may help to avoid surgical complications in future patients by identifying patient and surgical factors that might affect neuromonitoring results. Participants will be patients whose surgeons have already determined that lateral lumbar interbody fusion is the best treatment option for their spinal condition. Researchers will capture observational details of otherwise routine and standard-of-care surgical treatment, surgical monitoring, and follow-up.


Eligibility

  • * 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.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Advanced Techniques in Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure: A Utility Study

Study Details
Disease Type/Condition

Other

Principal Investigator

Walker, Corey

Age Group

Adult

Phase

N/A

IRB Number

STUDY00002942

ClinicalTrials.gov ID

NCT05648474

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Walker, Corey

Age Group

Adult

Phase

N/A

IRB Number

ATEC-AI-2001

ClinicalTrials.gov ID

NCT05648474

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org