Lumbar Fusion With Porous Versus Non-Porous Cages
NCT05583864 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2026-02-13
Summary
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.
Conditions
- Spinal Fusion
- Lumbar Fusion
- Arthrodesis
- Spondylolisthesis
- Pseudarthrosis
Interventions
- DEVICE
-
CONDUIT Porous Titanium Spinal Cage
Already included in arm/group descriptions.
- DEVICE
-
PROTI 360 Titanium-Coated PEEK Spinal Cage
Already included in arm/group descriptions.
Sponsors & Collaborators
-
Francis Farhadi
lead OTHER
Principal Investigators
-
Francis Farhadi, MD, PhD · University of Kentucky
-
Craig van Horne, MD, PhD · University of Kentucky
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-01
- Primary Completion
- 2026-03-31
- Completion
- 2027-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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