Lumbar Fusion With Porous Titanium Versus Non-Porous Titanium-Coated PEEK Interbody Cages - A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Kentucky
University of Kentucky
RECRUITING
Lexington
Contact Information
Primary
Francis Farhadi, MD, PhD
francis.farhadi@uky.edu
859-323-5661
Backup
Kris P Dyer, MPH
kris.dyer@uky.edu
859-323-4533
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2026-05
Participants
Target number of participants: 108
Treatments
Active_comparator: CONDUIT Porous Titanium Spinal Cage
Solid titanium spinal cage, infused with microscopic, porous canals to allow for adhesion and proliferation of bone graft factors contributing to spinal ossification, and ultimately, spinal fusion between vertebrae demonstrating instability.
Active_comparator: PROTI 360 Titanium-Coated PEEK Spinal Cage
Spinal cage composed primarily of a medical-grade polymer: poly-ether-ether-ketone (PEEK), with a titanium coating that is etched, but lacking porous features. These design features also attempt to stimulate spinal vertebrae fusion through bone-graft ossification and enhance vertebral stability.
Related Therapeutic Areas
Sponsors
Leads: University of Kentucky

This content was sourced from clinicaltrials.gov