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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

Not Yet Recruiting
Not specifiedAges 22–80Observational
Retropsoas Technologies, LLC
~120 participants
Updated 2025-06-13 on ClinicalTrials.gov
What's tested:Device: Nerve Cuff and Retractor System

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiographic measurements prior to surgery and at follow-up visits
Measured over From enrollment until the end of follow-up at 12 months
+1 more outcome measured

Conditions

Transforaminal Lumbar Interbody Fusion Surgery

NCT07020000

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Alleghany Health Network

    Pittsburgh, Pennsylvaniastudy coordinator listed

  • Northwell/Phelps

    Sleepy Hollow, New Yorkstudy coordinator listed

  • Rothman Orthopaedic Institute

    Philadelphia, Pennsylvaniastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Medical Director
[email protected]
618-402-0035
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Undergoing LIF between L2-S1

Exclusion

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

What this trial measures

  • Radiographic measurements prior to surgery and at follow-up visitsFrom enrollment until the end of follow-up at 12 months

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

  • To evaluate the safety of the EARP surgical technique and devices used during LIF surgeriesFrom surgery until the end of follow up at 12 months

    Adverse Device Events and surgical complications due to the devices