What side effects are associated with this type of intervention?

Common treatments for Spondylolisthesis, such as lumbar fusion using interbody cages, can have side effects including infection, nerve damage, blood clots, and anesthesia-related issues. Titanium cages like the Medtronic Adaptix™ may cause allergic reactions or metal sensitivity, while PEEK cages like the CAPSTONE® may have issues with subsidence and potentially lower fusion rates. Both materials aim to stabilize the spine and promote bone growth, but their specific properties can influence the risk of complications.

What prior FDA approvals exist?

The FDA has approved various treatments for Spondylolisthesis, particularly focusing on spinal fusion procedures that use interbody cages. The Medtronic Adaptix™ cage, with its roughened micro and nano-textured titanium surfaces, and the CAPSTONE® cage, made from poly-ether-ether-ketone (PEEK), are examples of such devices. These cages are designed to provide structural support and promote bone growth between vertebrae. Other FDA-approved treatments include the use of bone graft materials and biologics like bone morphogenetic proteins (BMPs) to enhance fusion outcomes. These devices and materials aim to stabilize the spine, alleviate pain, and improve patient mobility.

What other types of research exist?

Promising novel alternatives for Spondylolisthesis treatment in 2024 include: 1) 3D-printed titanium cages, which offer customizable designs and enhanced osseointegration; 2) Bioactive glass cages, which promote bone growth and reduce infection risk; and 3) Hybrid cages combining PEEK and titanium, providing the benefits of both materials such as radiolucency and strength.

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Implant

Titanium vs Polymer Spinal Cages for Spinal Conditions

N/A

Recruiting

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the Medtronic Adaptix™ titanium cage or Medtronic CAPSTONE® PEEK cage in conjunction with a 50:50 mixture of local autograft and GRAFTON™ DBM DBF, and supplementation with a pedicle screw system

Subject has been unresponsive to conservative care for a minimum of 6 months

Must not have

Subjects requiring additional bone grafting materials other than local autograft bone or GRAFTON™ DBM DBF

Subject has an active local or systemic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two different types of spinal implants in patients needing back surgery to see which one works better. The implants help stabilize the spine and promote bone growth to fuse the vertebrae together.

Who is the study for?

Adults over 18 needing lumbar fusion surgery for conditions like spondylolisthesis or degenerative disc disease, who've had no relief from 6 months of conservative care. Excludes those with prior lumbar surgery, certain medical conditions, obesity (BMI >45), infections, metal sensitivities, substance abuse history, pregnancy/lactation plans within a year, and involvement in litigation or other studies.

What is being tested?

The trial compares two types of spinal fusion implants: Medtronic Adaptix™ titanium cage and CAPSTONE® PEEK cage. It aims to see which implant works better when used with local bone graft mix and pedicle screw systems in spine surgeries.

What are the potential side effects?

Potential side effects may include reactions to the implant materials such as inflammation or infection at the site of surgery, pain or discomfort post-operation, allergic reactions to the titanium or PEEK material if sensitive, and complications related to bone healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a specific spinal fusion surgery using Medtronic cages and GRAFTON™ mix.

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My condition hasn't improved after 6 months of standard treatment.

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need bone grafting materials beyond local autograft bone or GRAFTON™.

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I currently have an infection.

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I have an open wound near my surgery area or severe joint/bone issues.

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I have had spine fusion surgery in my lower back.

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My BMI is over 45, classifying me as morbidly obese.

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I have insufficient tissue over my surgery area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fusion rate at 6 months

Secondary study objectives

Timing of fusion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Medtronic Adaptix™ titanium implantsExperimental Treatment1 Intervention

This arm will use Medtronic Adaptix™ titanium implants supplemented with a pedicle screw system. Both cages will be used in conjunction with a 50:50 mixture of autograft: allograft using milled local autograft bone and GRAFTON™ DBM DBF (no iliac crest autograft will be utilized).

Group II: Medtronic CAPSTONE® PEEK cageActive Control1 Intervention

This arm will use Medtronic CAPSTONE® PEEK cage supplemented with a pedicle screw system. Both cages will be used in conjunction with a 50:50 mixture of autograft: allograft using milled local autograft bone and GRAFTON™ DBM DBF (no iliac crest autograft will be utilized).

0 / 9Eligibility criteria met

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

The most common treatments for spondylolisthesis, particularly in cases requiring surgical intervention, involve spinal fusion procedures using interbody cages. The Medtronic Adaptix™ cage, with its roughened micro and nano-textured titanium surfaces, aims to enhance bone growth and fusion by providing a more conducive surface for bone cells to adhere and proliferate. This can lead to a more robust and quicker fusion process. On the other hand, the CAPSTONE® cage, made from poly-ether-ether-ketone (PEEK), is designed to be radiolucent, allowing for better post-operative imaging to monitor the fusion process. Both types of cages aim to stabilize the spine, reduce pain, and prevent further slippage of the vertebrae. The choice of cage material and design can significantly impact the fusion success rate and the patient's recovery, making it a critical consideration in the treatment of spondylolisthesis.

Does nanoscale porous titanium coating increase lumbar spinal stiffness of an interbody fusion cage? An in vivo biomechanical analysis in an ovine model.Polyetheretherketone (PEEK) cages in cervical applications: a systematic review.Is PEEK cage better than titanium cage in anterior cervical discectomy and fusion surgery? A meta-analysis.