Evaluating a new nerve monitoring technique during TLIF surgery
Evaluation Of A Novel Technique To Monitor Neurophysiological Activity During TLIF Surgery Using The Endoscopic Assisted Retropsoas (EARP) Nerve Cuff Electrode and Retractor With A Commercially Available Lumbar Spine Retractor System
This study is testing a new nerve monitoring tool during back surgery to see if it can better protect nerves and improve safety compared to standard methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 22 Years to 80 Years |
| Sex | All |
| Sponsor | Retropsoas Technologies, LLC Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT06204900 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness and safety of a novel surgical monitoring technique using the Endoscopic Assisted Retropsoas (EARP) Nerve Cuff Electrode and Retractor against standard nerve monitoring tools during Transforaminal Lumbar Interbody Fusion (TLIF) surgery. The study will assess how well these devices monitor nerve root function and reduce the risk of nerve damage during surgery. By utilizing both traditional and new monitoring methods, the research seeks to improve surgical outcomes and patient safety.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled to undergo TLIF surgery between the L2 and S1 vertebrae.
Not a fit: Patients requiring TLIF surgery only at the L5-S1 level or those with acute lumbar spine trauma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of TLIF surgeries, potentially reducing nerve damage and improving recovery outcomes for patients.
How similar studies have performed: While the approach of using nerve cuff electrodes is innovative, similar studies have shown varying degrees of success in improving nerve monitoring during spinal surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Undergoing TLIF between L2-S1 Exclusion Criteria: * Requiring TLIF surgery only at the L5-S1 level * Acute lumbar spine trauma requiring immediate intervention * Allergy or contraindication to propofol * Lower extremity amputation * Significant lower extremity edema noted on clinical exam * Current treatment with chemotherapy, radiation, or immunosuppression * Pregnant, or plans on becoming pregnant in the near future * History of allergy to titanium, platinum, aluminum, stainless steel, or silicon
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States (Recruiting)
- Allegheny-Singer Research Institute — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Nicholas Poulos, M.D.
- Email: npoulos@retropsoas.com
- Phone: (618) 402-0035
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.