The Objective of the Protocol is to Generate Real World Evidence (RWE) Supporting the Safety, Performance, and Health Economics of Using the Regulatory Approved and Commercially Available EARP Interbody System Used During Lumbar Interbody Fusion (LIF) Procedures With the EARP Nerve Cuff Electrode

Launched by RETROPSOAS TECHNOLOGIES, LLC · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on studying the safety and effectiveness of a specific surgical system called the EARP Interbody System, which is used during a type of back surgery known as Lumbar Interbody Fusion (LIF). The goal is to gather real-world evidence about how well this system works and whether it is cost-effective for patients. Researchers want to ensure that the EARP devices are safe to use and can help patients achieve better healing and improved space in the spine over time.

To be eligible for this trial, participants must be planning to undergo LIF surgery between specific vertebrae in the lower back. However, there are some key exclusions, such as individuals with a high body mass index (BMI over 40), those who are pregnant or planning to become pregnant, and patients with certain back conditions or previous surgeries that could complicate the study. The trial is not yet recruiting participants, but it will include individuals of all genders between the ages of 18 and 80. If someone qualifies and decides to participate, they can expect to be part of an important study that aims to improve back surgery outcomes for future patients.

Gender

ALL

Eligibility 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