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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is comparing two types of cages used in a type of back surgery. One is made of titanium and the other is made of a polymer.
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.Check my eligibility
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.See study design
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 belowSelect...
I am scheduled for a specific spinal fusion surgery using Medtronic cages and GRAFTON™ mix.
Select...
My condition hasn't improved after 6 months of standard treatment.
Select...
I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fusion rate at 6 months
Secondary outcome measures
Timing of fusion
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).
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,643 Total Patients Enrolled
4 Trials studying Spondylolisthesis
231 Patients Enrolled for Spondylolisthesis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I take medication that could affect bone or tissue healing.I currently have an infection.I have an open wound near my surgery area or severe joint/bone issues.I have had spine fusion surgery in my lower back.I am scheduled for a specific spinal fusion surgery using Medtronic cages and GRAFTON™ mix.My condition hasn't improved after 6 months of standard treatment.My BMI is over 45, classifying me as morbidly obese.I am over 18 years old.I have insufficient tissue over my surgery area.I am mentally and physically capable of following the study's requirements.I need bone grafting materials beyond local autograft bone or GRAFTON™.You are allergic to the antibiotic gentamicin or the processing solutions used in GRAFTON™.You are sensitive or allergic to metals or other foreign substances.
Research Study Groups:
This trial has the following groups:- Group 1: Medtronic CAPSTONE® PEEK cage
- Group 2: Medtronic Adaptix™ titanium implants
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.
What is the sample size for this experiment?
"Affirmative, clinicaltrials.gov reflects that this scientific experiment is actively recruiting. The trail was initially shared on October 13th 2021 and subsequently updated January 6th 2022. 100 study participants are required from one healthcare facility."
Answered by AI
Are there currently any opportunities available for participants to join this trial?
"Correct. According to clinicaltrials.gov, the research began recruiting on October 13th 2021 and is still ongoing as of January 6 2022. The study requires 100 participants from one site."
Answered by AI
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