Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAlphatec Spine, Inc.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Somatosensory evoked potential [SSEP] intraoperative monitoring

Treatment groups

400 Participants
are divided into 1 treatment group

Sponsors and collaborators