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

N/ANot Yet RecruitingNCT07020000

Retropsoas Technologies, LLC120 enrolled

Overview

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.

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

120

Conditions

Transforaminal Lumbar Interbody Fusion Surgery

Interventions

Eligibility

Sex: ALLMin age: 22 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

Northwell/Phelps

Sleepy Hollow, New York, United States

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Alleghany Health Network

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Radiographic measurements prior to surgery and at follow-up visits

Radiographic measurements including X-Ray, CT Scans, and MRIs if available

Time frame: 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

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

Secondary Outcomes

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

The Oswestry Disability Index (ODI)

Time frame: 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

Time frame: 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

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