Who is eligible for clinical trial NCT05583864?

Participants must meet protocol criteria for Spinal Fusion. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05583864 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-02

Lumbar Fusion With Porous Versus Non-Porous Cages (NCT05583864)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Francis Farhadi

🩺 Plain-English Summary (8th-Grade Level)

The objective of this single site, randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the following interventions: 1. Porous titanium cages 2. Non-porous titanium-coated poly-ether-ether-ketone (PEEK) cages.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (15 items).

Location: University of Kentucky — Lexington, Kentucky

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Patients will be considered for inclusion if:
They are scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the DePuy Synthes CONDUIT™ porous titanium cage or the DePuy Synthes PROTI 360º™ non-porous titanium-coated PEEK cage in conjunction with local autograft bone, and supplementation with a pedicle screw system.
They are over the age of 18 years old.
They have been unresponsive to conservative care for a minimum of 6 months.
They are in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.

Usually NOT eligible if any of the following apply:

Exclusion Criteria: Certain comorbidities and medical statuses may render patients ineligible for surgery, or put them at an increased risk for complications or injury by participating in the study. Therefore, patients will be excluded from enrollment if:
They have had previous lumbar arthrodesis surgery.
They require additional bone grafting materials other than local autograft bone.
There is inadequate tissue coverage over the operative site.
There is an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
Subject has a condition requiring medications that may interfere with bone or soft tissue healing(i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
Subject has an active local or systemic infection.
Subject has a metal sensitivity/foreign body sensitivity (cages will be implanted).
Subject is morbidly obese, defined as a body mass index (BMI) greater than 40.
Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
Subject is currently involved in another investigational drug or device study that could confound study data.
There is a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Kentucky — Lexington, Kentucky

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗