Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Transforaminal Lumbar Interbody Fusion Surgery
Keywords: Transforaminal Lumbar Interbody Fusion Surgery
TLIF
EARP
Retropsoas Technologies, LLC
Lead sponsor: Retropsoas Technologies, LLC
Sponsor class: INDUSTRY
First posted: 2025-06-13
Enrollment: 120
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient undergoing LIF between L2-S1and surgeon feels is a good candidate for the EARP Procedure

Brief summary: 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.

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.

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

Primary outcomes:
measure: Radiographic measurements prior to surgery and at follow-up visits
timeFrame: From enrollment until the end of follow-up at 12 months
measure: To evaluate the safety of the EARP surgical technique and devices used during LIF surgeries
timeFrame: From surgery until the end of follow up at 12 months
Secondary outcomes:
measure: Assess the ability of the EARP fusion system to reduce pain and restore function
timeFrame: Baseline to final follow-up visit at 12 months
measure: Assess IONM data during procedure related to the effectiveness of the EARP Nerve Cuff Electrode
timeFrame: During Surgery
measure: Quantify health economic factors associated with the EARP fusion system for LIF procedures
timeFrame: From surgery to end of follow up at 12 months
Other outcomes:
Locations:
city: Sleepy Hollow
country: United States
facility: Northwell/Phelps
state: New York
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Alleghany Health Network
state: Pennsylvania
Study officials:
References: