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Interbody Device
Tritanium C Cage for Degenerative Disc Disease (STRYKER Trial)
N/A
Recruiting
Led By Jad G Khalil, MD
Research Sponsored by William Beaumont Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing a one or two (contiguous) level primary ACDF between C2-T1
≥ 18 years of age and skeletally mature
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months postoperative
Awards & highlights
STRYKER Trial Summary
This trial will study the Stryker Tritanium C interbody device for treating degenerative disc disease at one or two levels in the cervical spine.
Who is the study for?
This trial is for adults over 18 with cervical spine issues like herniated discs or degenerative disc disease, who've tried non-surgical treatments without success. It's not for those needing more than two-level fusion, with severe obesity, infections, certain bone diseases, compromised immune systems due to treatments like chemotherapy or conditions that could affect study participation.Check my eligibility
What is being tested?
The study tests the Tritanium C Anterior Cervical Cage in patients undergoing a one or two-level ACDF surgery between the neck and upper back (C2-T1). The goal is to assess how well this device helps bones fuse after surgery and improves patient outcomes.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks of spinal fusion include pain at the graft site, nerve injury leading to weakness/numbness/pain, infection risk at the surgical site and potential implant-related complications.
STRYKER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having a neck surgery involving 1 or 2 levels from C2 to T1.
Select...
I am 18 years or older and my bones have stopped growing.
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I have neck or arm pain with a severity of 4 or more.
STRYKER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months postoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of successful cervical fusion measured radiographically
Secondary outcome measures
Count of participants with development of pseudoarthrosis by month 12
Count of participants with revision surgery by month 12
Eating Assessment Tool - 10 for Dysphagia
+4 moreSTRYKER Trial Design
1Treatment groups
Experimental Treatment
Group I: Tritanium C Anterior Cervical CageExperimental Treatment1 Intervention
50 subjects undergoing anterior cervical discectomy and fusion surgery using the Tritanium C Cervical Cage at one or two-levels
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Who is running the clinical trial?
William Beaumont HospitalsLead Sponsor
149 Previous Clinical Trials
112,808 Total Patients Enrolled
Stryker SpineIndustry Sponsor
6 Previous Clinical Trials
5,295 Total Patients Enrolled
Jad G Khalil, MDPrincipal InvestigatorBeaumont Health
2 Previous Clinical Trials
59 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a spine condition causing pain or nerve symptoms.I have had a fracture in my spine or due to weak bones.I am currently on chemotherapy, radiation, or taking immunosuppressants or steroids.I am having a neck surgery involving 1 or 2 levels from C2 to T1.I've tried non-surgical treatments for over 6 weeks for my neck condition without improvement.I have a neurological condition that might affect my neck function and pain levels.I am 18 years or older and my bones have stopped growing.I have been cancer-free for 3 years, except for skin cancer.I need surgery to fuse more than two sections of my neck vertebrae.I do not have any ongoing serious infections.I need urgent treatment for a neck injury.I have a bone condition that prevents me from having spinal surgery.Your neck disability score is equal to or higher than 20 before starting the study.You have a body mass index (BMI) greater than 40.You have had an allergic reaction to titanium in the past.I have neck or arm pain with a severity of 4 or more.I have had surgery to fuse bones in my neck.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Tritanium C Anterior Cervical Cage
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment capacity of this clinical investigation?
"Affirmative. Clinicaltrials.gov reveals that this medical experiment, first made available on May 5th 2021, is presently in search of participants. Approximately 50 patients across a single location are necessary to complete the study's requirements."
Answered by AI
Are there any vacancies remaining for participants in this trial?
"Per clinicaltrials.gov, this investigation is presently accepting participants which it began recruiting for on 5/5/2021; its most recent update being 6/27/2022."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
3+
What site did they apply to?
William Beaumont Hospital
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