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 (EARP-2)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Transforaminal Lumbar Interbody Fusion Surgery
• Intervention / Treatment: Device: Device: Nerve Cuff and Retractor System

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Medical Director; Phone Number: 618-402-0035; Email: npoulos@retropsoas.com

Study Locations

• United States
  • New York
    • Sleepy Hollow, New York, United States, 10591
      • Northwell/Phelps
      • Contact: Principal investigator; Phone Number: 914-366-3000; Email: ezgonis@northwell.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute
      • Contact: Principal investigator; Phone Number: 267-339-3615; Email: Thema.Nicholson@rothmanortho.com
    • Pittsburgh, Pennsylvania, United States, 15212
      • Alleghany Health Network
      • Contact: Principal investigator; Phone Number: 412-359-3565; Email: sarah.kimutis@ahn.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any patient undergoing LIF between L2-S1and surgeon feels is a good candidate for the EARP Procedure

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic measurements prior to surgery and at follow-up visits	Radiographic measurements including X-Ray, CT Scans, and MRIs if available	From enrollment until the end of follow-up at 12 months
To evaluate the safety of the EARP surgical technique and devices used during LIF surgeries	Adverse Device Events and surgical complications due to the devices	From surgery until the end of follow up at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the ability of the EARP fusion system to reduce pain and restore function	The Oswestry Disability Index (ODI)	Baseline to final follow-up visit at 12 months
Assess IONM data during procedure related to the effectiveness of the EARP Nerve Cuff Electrode	IONM data during surgical procedure	During Surgery
Quantify health economic factors associated with the EARP fusion system for LIF procedures	Health economic data including OR time, operative time, hospital length of stay, anesthetic technique, unilateral vs. bilateral fixation, bone graft choice	From surgery to end of follow up at 12 months

Collaborators and Investigators

• Sponsor: Retropsoas Technologies, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: June 5, 2025
• First Submitted That Met QC Criteria: June 12, 2025
• First Posted (Actual): June 13, 2025

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: TLIF; EARP; Transforaminal Lumbar Interbody Fusion Surgery; Retropsoas Technologies, LLC
• Other Study ID Numbers: EARP-2-1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in publications, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

For individual participant data meta-analysis.

Information can be accessed by contacting the Sponsor directly (contact info TBD)

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes