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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

Recruitingn/aAges 22 Years - 80 YearsAllRetropsoas Technologies, LLC
NCT07020000 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Device: Nerve Cuff and Retractor System
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Where

5 sites
Mayo Clinic
Jacksonville, United States
Barnes Jewish Hospital
St Louis, United States
Rothman Orthopaedic Institute
Philadelphia, United States
Alleghany Health Network
Pittsburgh, United States
Texas Orthopedic Hospital
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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