Using EARP devices during lumbar fusion to test safety and outcomes
Official title: A Multi-Center Post-Marketing Data Collection Protocol to Evaluate the Safety, Performance, and Health Economics of the Endoscopic Assisted Retropsoas (EARP) Interbody System for Lumbar Interbody Fusion Surgery
Run by Retropsoas Technologies, LLC · NCT07020000 · Data updated 2026-11-12
This study looks at whether using the EARP nerve cuffs during TLIF/LIF surgeries is safe and helps achieve fusion and better disc spacing.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 22 Years to 80 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Retropsoas Technologies, LLC Industry-sponsored |
| Locations | 5 sites (Jacksonville, Florida and 4 other locations) |
| Status | Recruiting |
| Started | October 22, 2026 |
| Main results expected | December 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT07020000 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults undergoing LIF between L2 and S1 who are suitable for EARP-assisted surgery and consent to participate.
✕Probably not a fit
Patients not meeting criteria or with exclusions (e.g., high BMI, prior fusion complications, certain spine conditions) may not experience a benefit from the EARP devices.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi-center post-marketing study collects real-world data on patients undergoing lumbar interbody fusion with the EARP Interbody System and EARP Nerve Cuff Electrode. The trial tracks safety, fusion status, radiographic changes, and patient function over 12 months, along with economic data. Eligible patients receive standard surgical care with the EARP devices, and outcomes are measured at 6 weeks, 3 months, 6 months, and 12 months. Imaging, ODI scores, and cost data are analyzed to understand performance and cost-effectiveness in routine practice.
Why it matters
Potential benefit: If successful, patients may experience safer nerve monitoring during surgery and potentially improved fusion and function with the EARP system.
How similar studies have gone: Prior post-marketing studies of similar interbody systems have shown variable safety and fusion outcomes, but this approach with EARP is being explored in real-world practice.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Undergoing LIF between L2-S1 Exclusion Criteria: * BMI \>40 kg/m2 * Pregnant or plans on becoming pregnant in the near future * Surgery requires combination of EARP with another lumbar interbody fusion technique (PLIF, TLIF, ALIF, OLIF, LLIF) or posterolateral fusion at another level * History of lumbar interbody pseudoarthrosis at planned operative level * Lumbar spondylolisthesis ≥ grade 3 * Osteoporotic vertebral compression fracture treated or untreated at planned operative site * History of lumbar spinal metastasis * Acute lumbar spine trauma requiring immediate intervention * Owestry Disability Index (ODI) 81-100% * Presence of personality disorder or major psychiatric illness * History of allergy to titanium, platinum, PEEK, aluminum, stainless steel or silicone * Any additional factor that makes the patient an unsuitable candidate for the study in the opinion of the principal investigator
Where it's running
-
Mayo Clinic
Jacksonville, Florida, United States Recruiting -
Barnes Jewish Hospital
St Louis, Missouri, United States Recruiting -
Alleghany Health Network
Pittsburgh, Pennsylvania, United States Recruiting -
Texas Orthopedic Hospital
Houston, Texas, United States Recruiting -
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States Not yet recruiting
Study contacts
- Study coordinator: Nicholas Medical Director, MD
- Email: npoulos@retropsoas.com
- Phone: 618-402-0035
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.