What side effects are associated with this type of intervention?

Common side effects of lumbar fusion procedures include infection, bleeding, nerve damage, and pain at the graft site. Specific to the materials used, Porous Titanium Cages, which provide a scaffold for bone growth, may lead to issues such as implant migration or subsidence. Non-Porous Titanium-Coated PEEK Cages, offering a biocompatible surface with structural benefits, may also present risks like implant loosening or allergic reactions to the materials. Both types of cages aim to enhance fusion rates and stability, but careful monitoring for these potential complications is essential.

What other types of research exist?

Promising novel alternatives for lumbar fusion patients in 2024 include bioactive glass and 3D-printed custom implants. Bioactive glass promotes bone growth and integration by releasing ions that stimulate cellular activity. 3D-printed custom implants can be tailored to patient-specific anatomy, offering enhanced fit and potentially better outcomes.

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Spinal Cage

Porous vs Non-Porous Cages for Lumbar Fusion

Q: What prior FDA approvals exist?

The FDA has approved various devices for lumbar fusion, including both porous titanium cages and non-porous titanium-coated PEEK cages. Porous titanium cages are designed to facilitate bone growth and integration by providing a scaffold-like structure, enhancing the fusion process. Non-porous titanium-coated PEEK cages offer a biocompatible surface that combines the structural benefits of PEEK with the added advantage of a titanium coating, which can improve osseointegration. These devices are part of a broader category of interbody fusion cages that have been approved to stabilize the spine and promote bone fusion in patients undergoing lumbar fusion surgery.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and six months following procedure for reporting.

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.

Do I qualify?Apply below to find out

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.