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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:
Select...
I need bone grafting materials beyond local autograft bone or GRAFTON™.
Select...
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.
Select...
I have insufficient tissue over my surgery area.

Timeline

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).

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.

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
864 Previous Clinical Trials
654,340 Total Patients Enrolled
4 Trials studying Spondylolisthesis
231 Patients Enrolled for Spondylolisthesis

Media Library

Medtronic Adaptix™ titanium implants (Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05182489 — N/A
Spondylolisthesis Research Study Groups: Medtronic CAPSTONE® PEEK cage, Medtronic Adaptix™ titanium implants
Spondylolisthesis Clinical Trial 2023: Medtronic Adaptix™ titanium implants Highlights & Side Effects. Trial Name: NCT05182489 — N/A
Medtronic Adaptix™ titanium implants (Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05182489 — N/A
~3 spots leftby Nov 2024