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)

Retropsoas Technologies

Status: Begins enrollment in 1 month

Conditions: Transforaminal Lumbar Interbody Fusion Surgery

Treatments: Device: Device: Nerve Cuff and Retractor System

Study type: Observational

Funder types: Industry

Identifiers

NCT07020000

EARP-2-1002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 22 to 80 years old

Volunteers: No Healthy Volunteers

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