50 Participants Needed

Tritanium C Cage for Degenerative Disc Disease

(STRYKER Trial)

Recruiting at 1 trial location
GS
PS
Overseen ByPamela Sloan, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that using titanium cages in anterior cervical discectomy and fusion is effective for treating degenerative disc disease, with a high percentage of patients experiencing good outcomes and reduced neck pain.12345

Is the Tritanium C Cage generally safe for use in humans?

The use of titanium cages, similar to the Tritanium C Cage, in anterior cervical discectomy and fusion (ACDF) has been shown to be safe, with studies indicating good mechanical stability and a lower risk of complications like cage subsidence and adjacent segment degeneration.36789

What makes the Tritanium C Anterior Cervical Cage treatment unique for degenerative disc disease?

The Tritanium C Anterior Cervical Cage is unique because it is designed specifically for spinal fusion in the cervical spine, using a 3D-printed titanium material that promotes bone growth and stability, which may offer advantages over traditional materials used in spinal surgeries.1011121314

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

JG

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

I have been diagnosed with a spine condition causing pain or nerve symptoms.
Able to provide consent
I am having a neck surgery involving 1 or 2 levels from C2 to T1.
See 3 more

Exclusion Criteria

I have had a fracture in my spine or due to weak bones.
I am currently on chemotherapy, radiation, or taking immunosuppressants or steroids.
Psychological or physical condition in the opinion of the investigator that would interfere with completing study participation including completion of patient reported outcomes
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo anterior cervical discectomy and fusion surgery using the Tritanium C Cervical Cage at one or two levels

1 day
1 visit (in-person)

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

24 months
5 visits (in-person)

Treatment Details

Interventions

  • Tritanium C Anterior Cervical Cage
Trial Overview 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials
153
Recruited
113,000+

Stryker Spine

Industry Sponsor

Trials
7
Recruited
5,400+

Findings from Research

In a study of 78 patients undergoing anterior discectomy and fusion for cervical degenerative disc disease, the use of a non-threaded titanium cage resulted in a high fusion rate of 95% at 24 months, indicating its effectiveness for structural reconstruction.
The procedure led to significant improvements in neurologic outcomes, with 92% of patients with radiculopathy reporting excellent or good results, and no surgery-related complications were observed, highlighting the safety of this method.
Outcome analyses of interbody titanium cage fusion used in the anterior discectomy for cervical degenerative disc disease.Hwang, SL., Hwang, YF., Lieu, AS., et al.[2022]
In a study of 138 patients undergoing anterior cervical fusion with cylindrical cages, significant radiologic changes were observed over a mean follow-up of 38.61 months, including high rates of cage subsidence and osteophyte formation, particularly in the anterior portion.
Despite these changes, severe neurological complications were not reported, suggesting that while cylindrical cages can lead to structural changes, they may still be safe when used in carefully selected cases.
Long-term follow-up radiologic and clinical evaluation of cylindrical cage for anterior interbody fusion in degenerative cervical disc disease.Kim, S., Chun, HJ., Yi, HJ., et al.[2021]
Titanium cage-assisted anterior cervical discectomy and fusion (ACDF) is effective for treating cervical degenerative disc disease, showing significant improvements in neurological outcomes and pain relief in both groups studied, with no significant differences between those with and without plate fixation.
The procedure without plate fixation resulted in a lower complication rate and shorter hospital stay compared to the plate fixation group, suggesting that cage-assisted ACDF without additional fixation may be a safer and more efficient option.
Three-level and four-level anterior cervical discectomies and titanium cage-augmented fusion with and without plate fixation.Hwang, SL., Lin, CL., Lieu, AS., et al.[2016]

References

Outcome analyses of interbody titanium cage fusion used in the anterior discectomy for cervical degenerative disc disease. [2022]
Long-term follow-up radiologic and clinical evaluation of cylindrical cage for anterior interbody fusion in degenerative cervical disc disease. [2021]
Three-level and four-level anterior cervical discectomies and titanium cage-augmented fusion with and without plate fixation. [2016]
Eleven-Year Follow-Up of Two Cohorts of Patients Comparing Stand-Alone Porous Tantalum Cage Versus Autologous Bone Graft and Plating in Anterior Cervical Fusions. [2019]
Polyetheretherketone cages alone with allograft for three-level anterior cervical fusion. [2023]
The biomechanical effects of S-type dynamic cage using Ti and PEEK for ACDF surgery on cervical spine varying loads. [2021]
Clinical effects of the bridge-type ROI-C interbody fusion cage system in the treatment of cervical spondylosis with osteoporosis. [2022]
Threaded interbody fusion cage for adjacent segment degenerative disease after previous anterior cervical fusion. [2016]
Carbon-fibre cage reconstruction in anterior cervical corpectomy for multilevel cervical spondylosis: mid-term outcomes. [2022]
Effect of cervical lesion centered access cavity restored with short glass fibre reinforced resin composites on fracture resistance in human mandibular premolars- an in vitro study. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Clinical evaluation of a polyacid-modified resin composite (Dyract) in Class III cavities: 5-year results. [2006]
The two-year clinical performance of esthetic restorative materials in noncarious cervical lesions. [2022]
Long-term clinical evaluation of Dyract compomer in the restoration of non-caries cervical lesions: A 20-year retrospective study. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
Technique on restoring sub-gingival cervical lesion. [2007]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security