Tritanium C Cage for Degenerative Disc Disease
(STRYKER Trial)
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.
What data supports the effectiveness of the Tritanium C Anterior Cervical Cage treatment for degenerative disc disease?
Is the Tritanium C Cage generally safe for use in humans?
What makes the Tritanium C Anterior Cervical Cage treatment unique for degenerative disc disease?
What is the purpose of this trial?
This is a prospective, single arm clinical study to evaluate fusion status and patient reported outcomes utilizing the Stryker Tritanium® C Anterior Cervical interbody device at one or two contiguous levels. Subjects that are recommended for surgical treatment of either a 1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) between the levels of Cervical Spine 2 to Thoracic 1 (C2-T1) and diagnosed with degenerative disc disease will be screened for the study.
Research Team
Jad G Khalil, MD
Principal Investigator
Beaumont Health
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo anterior cervical discectomy and fusion surgery using the Tritanium C Cervical Cage at one or two levels
Postoperative Follow-up
Participants are monitored postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months for fusion status and patient-reported outcomes
Treatment Details
Interventions
- Tritanium C Anterior Cervical Cage
Find a Clinic Near You
Who Is Running the Clinical Trial?
William Beaumont Hospitals
Lead Sponsor
Stryker Spine
Industry Sponsor