Monitoring nerve function during lumbar spine surgery
Advanced Techniques in Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure: a Utility Study
This study is testing if monitoring nerve signals during spine surgery can help protect nerves and improve safety for adults having lumbar fusion surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alphatec Spine, Inc. Industry-sponsored |
| Locations | 1 site (Carlsbad, California) |
| Trial ID | NCT05648474 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of intraoperative neuromonitoring using somatosensory evoked potentials (SSEP) to detect potential nerve changes during lateral lumbar interbody fusion (LLIF) surgery. The monitoring focuses on the saphenous nerve to assess the risk to lumbar nerves during the procedure. By identifying nerve changes in real-time, the study aims to enhance surgical outcomes and patient safety. Participants will be adults scheduled for 1- or 2-level LLIF surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for 1- or 2-level instrumented LLIF surgery.
Not a fit: Patients requiring surgery at more than 2 lumbar levels or those with conditions affecting nerve reliability may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and reduce the risk of nerve damage during lumbar spine surgeries.
How similar studies have performed: Previous studies utilizing intraoperative neuromonitoring techniques have shown promise in enhancing surgical safety, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Carlsbad, California
- Alphatec Spine Inc. — Carlsbad, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.