Tritanium C Cage for Degenerative Disc Disease

(STRYKER Trial)

Recruiting at 1 trial location

Overseen By Pamela Sloan, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: William Beaumont Hospitals

Must not be taking: Chemotherapy, Radiation, Immunosuppressants, Steroids

Disqualifiers: Cervical fusion history, BMI > 40, Osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

50 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{5 11 12 13 14}

Who Is on the Research Team?

Jad G Khalil, MD

Principal Investigator

Beaumont Health

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Tritanium C Anterior Cervical Cage Experimental Treatment 1 Intervention

50 subjects undergoing anterior cervical discectomy and fusion surgery using the Tritanium C Cervical Cage at one or two-levels

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A study of 57 patients (27 with a tantalum cage and 30 with autologous bone graft) showed that the clinical outcomes of anterior cervical discectomy and fusion were maintained over 11 years, indicating long-term efficacy of both methods.

While both groups experienced similar rates of adjacent segment degeneration, the tantalum cage group had a notable 44% incidence of cage subsidence, suggesting that while effective, the tantalum cage may have some long-term structural concerns compared to autologous bone graft.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Fernández-Fairen, M., Alvarado, E., Torres, A.[2019]

In a study of 25 patients with degenerative cervical disc disease who underwent three-level anterior cervical discectomy and fusion (ACDF) using PEEK cages and allograft, a fusion rate of 72% was achieved, indicating a moderate success in spinal fusion.

Postoperative results showed significant clinical improvements in patient symptoms, as measured by the Japanese Orthopedic Association (JOA) score and visual analog scales (VAS), suggesting that while the fusion rate was not high, the procedure effectively alleviated symptoms and maintained cervical spine alignment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyetheretherketone cages alone with allograft for three-level anterior cervical fusion. Liu, H., Ploumis, A., Li, C., et al.[2023]

The S-type dynamic cage designed for anterior cervical discectomy with fusion (ACDF) maintains motion at adjacent levels and reduces maximum stress on adjacent discs, which could lead to lower risks of degeneration and subsidence.

Using materials like titanium and PEEK, the dynamic cage shows improved biomechanical performance, suggesting it may enhance fusion rates and provide better mechanical stability post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The biomechanical effects of S-type dynamic cage using Ti and PEEK for ACDF surgery on cervical spine varying loads. Manickam, PS., Roy, S.[2021]

The ROI-C interbody fusion cage system is safe and effective for treating cervical spondylosis in patients with osteoporosis, showing significant improvements in clinical outcomes like JOA and NDI scores after surgery.

Postoperative radiographic parameters, including cervical curvature and intervertebral height, were significantly improved and maintained over a follow-up period of approximately 27 months, with only mild dysphagia reported in two patients that resolved quickly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effects of the bridge-type ROI-C interbody fusion cage system in the treatment of cervical spondylosis with osteoporosis. Rong, Y., Luo, Y., Liu, W., et al.[2022]

In a study of 7 patients with adjacent segment degeneration after cervical fusion, the use of threaded interbody fusion cages resulted in significant improvements in pain and function, with a 58% reduction in VAS pain scores and a 42% improvement in clinical outcomes.

All surgeries were performed without complications, and there was no incidence of pseudoarthrosis at the 24-month follow-up, indicating that this technique is safe and effective for treating adjacent segment degeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Threaded interbody fusion cage for adjacent segment degenerative disease after previous anterior cervical fusion. Arnold, P., Boswell, S., McMahon, J.[2016]

A study of 102 patients undergoing anterior cervical corpectomy and fusion with carbon-fiber cages showed significant improvements in pain and neurological function, with mean neck pain scores decreasing from 4.6 to 2.6 and arm pain scores from 5.1 to 2.0 after surgery.

The carbon-fiber cages demonstrated a safety profile comparable to titanium mesh cages, with a 13% incidence of severe subsidence (>3 mm) and a low rate of peri-operative complications, suggesting they are a durable option for treating multilevel cervical spondylosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbon-fibre cage reconstruction in anterior cervical corpectomy for multilevel cervical spondylosis: mid-term outcomes. Cawley, DT., Alzakri, A., Fujishiro, T., et al.[2022]

Short glass fibre reinforced resin composites significantly improve the fracture resistance of endodontically treated mandibular premolars, regardless of whether a traditional or cervical lesion centered access cavity design is used.

The cervical lesion centered access cavity design, when restored with fibre reinforced materials, showed better fracture resistance compared to unrestored cavities, but the difference was not statistically significant compared to traditional designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Shilpa-Jain, DP., Krithikadatta, J., Kowsky, D., et al.[2021]

In a study involving 62 Class III cavities restored with Dyract resin composite over 5 years, the cumulative failure rate was 94.6%, indicating a high rate of restoration failure.

The main reasons for restoration failure included one case of pulpitis and five cases of secondary caries, with significant marginal discoloration observed by the 5-year recall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a polyacid-modified resin composite (Dyract) in Class III cavities: 5-year results. Demirci, M., Ersev, H., Sancakli, HS., et al.[2006]

In a study involving 30 patients and 130 restorations over two years, Vitremer showed a 100% retention rate, making it the most effective material for restoring noncarious cervical lesions compared to other materials like F2000 Compomer, Dyract AP, and Valux Plus.

While Vitremer excelled in retention, Valux Plus demonstrated the best overall performance in other categories, highlighting the need for clinicians to consider both retention and esthetics when choosing restoration materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The two-year clinical performance of esthetic restorative materials in noncarious cervical lesions. Onal, B., Pamir, T.[2022]

Dyract restorations for non-caries cervical lesions demonstrated a high survival rate of 70.4% after 20 years, indicating their long-term efficacy as a treatment option.

While Dyract restorations are effective, issues such as marginal discoloration and adaptation should be taken into account when considering their use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term clinical evaluation of Dyract compomer in the restoration of non-caries cervical lesions: A 20-year retrospective study. Alonso de la Peña, V., Darriba, IL., Caserío Valea, M.[2021]

The study presents a new atraumatic isolation technique combined with a conservative instrumentation sequence for effectively managing challenging deep proximal-cervical Class V dental lesions.

Utilizing a highly viscous, rapid-setting glass ionomer cement in this approach may enhance treatment outcomes by providing a strong and durable restoration while minimizing trauma to the surrounding tooth structure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique on restoring sub-gingival cervical lesion. Chan, DC., Adkins, J.[2007]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Outcome analyses of interbody titanium cage fusion used in the anterior discectomy for cervical degenerative disc disease. [2022]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Long-term follow-up radiologic and clinical evaluation of cylindrical cage for anterior interbody fusion in degenerative cervical disc disease. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Three-level and four-level anterior cervical discectomies and titanium cage-augmented fusion with and without plate fixation. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

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]

5. Egypt pubmed.ncbi.nlm.nih.gov

Polyetheretherketone cages alone with allograft for three-level anterior cervical fusion. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The biomechanical effects of S-type dynamic cage using Ti and PEEK for ACDF surgery on cervical spine varying loads. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical effects of the bridge-type ROI-C interbody fusion cage system in the treatment of cervical spondylosis with osteoporosis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Threaded interbody fusion cage for adjacent segment degenerative disease after previous anterior cervical fusion. [2016]

9. China pubmed.ncbi.nlm.nih.gov

Carbon-fibre cage reconstruction in anterior cervical corpectomy for multilevel cervical spondylosis: mid-term outcomes. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a polyacid-modified resin composite (Dyract) in Class III cavities: 5-year results. [2006]

12. England pubmed.ncbi.nlm.nih.gov

The two-year clinical performance of esthetic restorative materials in noncarious cervical lesions. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

Long-term clinical evaluation of Dyract compomer in the restoration of non-caries cervical lesions: A 20-year retrospective study. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Technique on restoring sub-gingival cervical lesion. [2007]