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NCT Number: NCT07020000

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

The goal of the trial is to generate data to support the safety, performance, and cost effectiveness of using the EARP devices during Lumbar Interbody Fusion (LIF) procedures.

The primary objectives are:

* To evaluate the safety of the EARP surgical technique and devices during LIF surgeries. * To understand the EARP fusion system's ability to achieve fusion and improve disk space over time.

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Key information

Conditions

Transforaminal Lumbar Interbody Fusion Surgery

Age range

22 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwell/Phelps, Sleepy Hollow, New York, United States

About this study

This multi-center post-marketing study will include consecutive patients who meet eligibility criteria, are scheduled to undergo a LIF procedure using the EARP Interbody System and EARP Nerve Cuff Electrode, and agree to participate. The study will include patients deemed appropriate for the procedure per the site's judgment, which may include patients with off-label use of the devices. Patients who consent to study participation and meet study criteria will undergo surgery according to site standard procedure. The EARP Nerve Cuff Electrode will be used to monitor nerve roots during surgery. Radiographic imaging will document the fusion status and various disk space parameters, and the Oswestry Disability Index (ODI) will be used to assess function and pain. Data will be collected from standard site follow-up visits at 6 weeks, 3 months, 6 months, and 12 months after surgery. Economic data will be collected to quantify the economics of the EARP Interbody System for LIF procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device: Nerve Cuff and Retractor System

Device

Endoscopic Assisted Retropsoas (EARP) Nerve Cuff Electrode and an EARP Retractor system to safely monitor lumbar nerve root activity and function during standard interbody fusion surgeries.

Primary outcomes

Radiographic measurements prior to surgery and at follow-up visits

Time frame: From enrollment until the end of follow-up at 12 months

Radiographic measurements including X-Ray, CT Scans, and MRIs if available
To evaluate the safety of the EARP surgical technique and devices used during LIF surgeries

Time frame: From surgery until the end of follow up at 12 months

Adverse Device Events and surgical complications due to the devices

Secondary outcomes

Assess the ability of the EARP fusion system to reduce pain and restore function

Time frame: Baseline to final follow-up visit at 12 months

The Oswestry Disability Index (ODI)
Assess IONM data during procedure related to the effectiveness of the EARP Nerve Cuff Electrode

Time frame: During Surgery

IONM data during surgical procedure
Quantify health economic factors associated with the EARP fusion system for LIF procedures

Time frame: From surgery to end of follow up at 12 months

Health economic data including OR time, operative time, hospital length of stay, anesthetic technique, unilateral vs. bilateral fixation, bone graft choice

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Director

CONTACT

[email protected]

618-402-0035

Sponsors and collaborators

Lead sponsor

Retropsoas Technologies, LLC

Industry

Registry information

Official study 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

Acronym: EARP-2

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Jun 13, 2025
Registry last updated: Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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