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Endoscopic Assisted Retropsoas (EARP) Interbody System for Lumbar Interbody Fusion Surgery

Overview

About this study

The purpose of this study is to evaluate the safety of the EARP surgical technique and devices used during LIF surgeriesand to assess the effectiveness of the EARP fusion system to achieve fusion and improve disk space parameters over time.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • ≥ 22 years of age and skeletally mature, and < 80 years of age
  • Able to provide consent
  •  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 2
  • 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 01/03/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Stephen Pirris, M.D.

Contact us for the latest status

Contact information:

Megan Gauthier

(904) 956-8393

Gauthier.Megan2@mayo.edu

More information

Publications

Publications are currently not available

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CLS-20582952

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