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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
Study Summary
This trial will compare the effectiveness of two different types of implants in a lumbar interbody fusion procedure.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brantigan-Steffee-Frasier (BSF) Fusion Scale
Secondary outcome measures
Back
Oswestry Disability Index (ODIv2.1a)
PROMIS-10 Global
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.
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Who is running the clinical trial?
University of KentuckyLead Sponsor
186 Previous Clinical Trials
226,576 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many patients have enrolled in this clinical investigation?
"Indeed, the information found on clinicaltrials.gov highlights that this medical examination is actively enrolling individuals. This experiment was initially posted on November 1st 2022 and most recently updated on 11/11/2022 with a recruitment goal of 108 participants from one site."
Answered by AI
Are participants of this study required to be under 30 years old?
"In order to participate in this medical trial, one must be between 18 and 80 years of age. For minors or senior citizens, there are 8 studies targeting those under 18 and 67 for adults over the age of 65."
Answered by AI
Does this study currently accept new participants?
"The clinical trial is actively seeking participants, having been first posted on the 1st November 2022 and edited as recently as 11th November."
Answered by AI
Is participation in this research endeavor open to the public?
"In order to be admitted into the trial, patients must possess a condition of pseudarthrosis and fall within the designated age range (18-80). A total of 108 participants will eventually take part in this clinical research."
Answered by AI
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