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Spinal Cage
Porous vs Non-Porous Cages for Lumbar Fusion
N/A
Recruiting
Led By Francis Farhadi, MD, PhD
Research Sponsored by University of Kentucky
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative, three, six, twelve, and twenty-four month follow-ups.
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two types of cages used in back surgery for patients needing spinal fusion. One cage is made of porous titanium, and the other is titanium-coated PEEK. The cages help bones in the spine grow together and stabilize.
Who is the study for?
This trial is for adults over 18 who need lumbar fusion surgery and haven't responded to non-surgical treatments for at least 6 months. They must be able to follow the study plan and give consent. Exclusions include previous lumbar fusion, substance abuse, pregnancy, ongoing litigation or compensation claims related to back pain, infections, metal sensitivity, extreme obesity (BMI >40), certain medical conditions or medications affecting bone healing.
What is being tested?
The trial compares two types of spinal cages used in lumbar fusion surgeries: one made from porous titanium and another coated with titanium on PEEK material. Participants will be randomly assigned to receive either cage during their scheduled surgery.
What are the potential side effects?
Potential side effects may include typical surgical risks such as infection, pain at the site of surgery, bleeding, nerve damage or reactions specific to the materials used in the cages like inflammation or allergic responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months following procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months following procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brantigan-Steffee-Frasier (BSF) Fusion Scale
Secondary study objectives
Back
Oswestry Disability Index (ODIv2.1a)
PROMIS-10 Global
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: CONDUIT Porous Titanium Spinal CageActive Control1 Intervention
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.
Group II: PROTI 360 Titanium-Coated PEEK Spinal CageActive Control1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Porous Titanium Cages provide a scaffold for bone growth and integration, promoting osseointegration by allowing bone tissue to grow into the porous structure, which enhances the stability and long-term success of the fusion. Non-Porous Titanium-Coated PEEK Cages offer a biocompatible surface that reduces the risk of adverse reactions while maintaining the structural benefits of PEEK, such as its radiolucency and mechanical properties similar to bone.
These mechanisms are crucial for lumbar fusion patients as they ensure better bone integration, stability, and compatibility, leading to improved clinical outcomes and reduced complications.
Additive-manufactured Ti-6Al-4 V/Polyetheretherketone composite porous cage for Interbody fusion: bone growth and biocompatibility evaluation in a porcine model.Endowing Polyetheretherketone Implants with Osseointegration Properties: In Situ Construction of Patterned Nanorod Arrays.
Additive-manufactured Ti-6Al-4 V/Polyetheretherketone composite porous cage for Interbody fusion: bone growth and biocompatibility evaluation in a porcine model.Endowing Polyetheretherketone Implants with Osseointegration Properties: In Situ Construction of Patterned Nanorod Arrays.
Find a Location
Who is running the clinical trial?
University of KentuckyLead Sponsor
194 Previous Clinical Trials
223,592 Total Patients Enrolled
Francis Farhadi, MD, PhDPrincipal InvestigatorUniversity of Kentucky
Craig van Horne, MD, PhDStudy DirectorUniversity of Kentucky
2 Previous Clinical Trials
80 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had spine fusion surgery in my lower back.I have insufficient tissue over my surgery area.I need more than just my own bone for a graft.My BMI is over 40.I am over 18 years old.I am mentally and physically capable of following the study's requirements.I currently have an infection.My condition hasn't improved after 6 months of standard treatment.I have an open wound near the surgery area or a specific health condition.I am scheduled for a specific type of spinal fusion surgery.
Research Study Groups:
This trial has the following groups:- Group 1: CONDUIT Porous Titanium Spinal Cage
- Group 2: PROTI 360 Titanium-Coated PEEK Spinal Cage
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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