Tritanium C Cage for Degenerative Disc Disease
(STRYKER Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byJad G Khalil, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: William Beaumont Hospitals
Must not be taking: Chemotherapy, Radiation, Immunosuppressants, Steroids
Disqualifiers: Cervical fusion history, BMI > 40, Osteoporosis, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
26789What 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.
1011121314Eligibility 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.
+4 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
+10 more
Trial 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)
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Corewell Health William Beaumont University HospitalRoyal Oak, MI
William Beaumont HospitalRoyal Oak, MI
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Who Is Running the Clinical Trial?
William Beaumont HospitalsLead Sponsor
Stryker SpineIndustry Sponsor
References
Long-term follow-up radiologic and clinical evaluation of cylindrical cage for anterior interbody fusion in degenerative cervical disc disease. [2021]Various procedures have been introduced for anterior interbody fusion in degenerative cervical disc disease including plate systems with autologous iliac bone, carbon cages, and cylindrical cages. However, except for plate systems, the long-term results of other methods have not been established. In the present study, we evaluated radiologic findings for cylindrical cervical cages over long-term follow up periods.
Three-level and four-level anterior cervical discectomies and titanium cage-augmented fusion with and without plate fixation. [2016]Cage-assisted anterior cervical discectomy and fusion (ACDF) has proven to be a safe and effective procedure for the treatment of one- and two-level degenerative disc disease (DDD). To the authors' knowledge, clinical results after three- and four-level interbody cage-augmented ACDF have not been reported in the literature. The authors investigated the safety and effectiveness of titanium cages used in such procedures and evaluated the results in cases with or without plate fixation.
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]Anterior cervical discectomy and fusion with a porous tantalum cage is an accepted method to treat degenerated cervical discs, with good results, similar to those with autologous bone graft and plating at short- and mid-term follow-up. However, to date, long-term follow-up studies have been performed.
Outcome analyses of interbody titanium cage fusion used in the anterior discectomy for cervical degenerative disc disease. [2022]Anterior discectomy and fusion to treat cervical degenerative disc disease is the preferred procedure for many spine surgeons. The ideal device for structural reconstruction of the anterior cervical spine remains controversial. The purpose of this prospective study was to investigate the effectiveness of a non-threaded titanium cage in performing anterior spinal fusion for cervical degenerative disc disease. The clinical and radiologic data of 78 consecutive patients were reviewed. Neurologic outcome was assessed using Odom's criteria. Neck pain was graded using a 10-point visual analog scale. The cervical spinal curvature, the height of foramina, and fusion status were evaluated on preoperative and postoperative radiographs. Mean follow-up was 24.9 (range 18-35) months. An excellent or good result was found in 92% of the patients with radiculopathy, 69% of those with myelopathy, and 73% of those with myeloradiculopathy. Statistical analyses also showed improvement of cervical pain after surgery (P
Polyetheretherketone cages alone with allograft for three-level anterior cervical fusion. [2023]A total of 25 consecutive patients suffering from degenerative cervical disc disease who underwent three-level anterior cervical discectomy and fusion (ACDF) including polyetheretherketone (PEEK) cages packed with allograft were followed up for at least two years. The fusion rate reached 72% (18/25), and asymptomatic pseudarthrosis was seen in 6 patients but without mobility on flexion-extension radiographs, and revision surgery was not needed. Cage subsidence occurred at one level (C67), but it was not progressive, and reoperation was not necessary. A significant increase (P
The biomechanical effects of S-type dynamic cage using Ti and PEEK for ACDF surgery on cervical spine varying loads. [2021]Anterior cervical discectomy with fusion (ACDF) is the common method to treat the cervical disc degeneration. The most serious problems in the fusion cages are adjacent disc degeneration, loss of lordosis, pain, subsidence, and migration of the cage. The objective of our work is to develop the three-dimensional finite element (FE) model from C3-C6 and virtually implant a designed S-type dynamic cage at C4-C5 segment of the model. The dynamic cage design will provide mobility in the early stage after ACDF surgery. Titanium (Ti) and PEEK (polyether ether ketone) were used as the material property for the cages. We applied the physiological motions at different loads from 0.5, 1, 1.5, 2.0 Nm to evaluate the dynamic cage design and the biomechanical performances of the designed S-type dynamic cage. It was observed that in all the loading condition the range of motion in the adjacent level was maintained and the maximum stress at the adjacent disc was reduced. The clinical significance of the S-type dynamic cage is better stress profile at the fusion level and adjacent segments which translates into higher rate of fusion, lower risk of cage subsidence, lower risk of adjacent segment degeneration, and good mechanical stability.
Clinical effects of the bridge-type ROI-C interbody fusion cage system in the treatment of cervical spondylosis with osteoporosis. [2022]To investigate the early and mid-term efficacy and safety of the bridge-type ROI-C interbody fusion cage system in the treatment of cervical spondylosis with osteoporosis during anterior cervical discectomy and fusion (ACDF).
Threaded interbody fusion cage for adjacent segment degenerative disease after previous anterior cervical fusion. [2016]Anterior discectomy and fusion have been used for over 50 years in the treatment of degenerative disease of the cervical spine. However, as these procedures become more common, the long-term consequences are becoming more evident. One such consequence is degeneration of an adjacent segment, which can occur in up to 17% of patients undergoing cervical fusion. A threaded interbody fusion cage has often been used in a primary degenerative disorder of the cervical spine. However, there have been no studies in which these cages have been used in adjacent segments after previous cervical fusion. This is a retrospective review of 7 patients to determine the fusion rate, operative utility, and clinical outcomes using a threaded fusion cage construct in the treatment of cervical adjacent segment degeneration.
Carbon-fibre cage reconstruction in anterior cervical corpectomy for multilevel cervical spondylosis: mid-term outcomes. [2022]Mid-term clinical and radiological evaluation of a carbon-fiber cage in multilevel cervical spondylosis (MCS). Anterior cervical corpectomy and fusion (ACCF) using titanium mesh cages (TMC) has shown satisfactory outcomes, but with subsidence of up to 20%. Conventional long-fiber carbon fiber cages have shown a safe profile in discectomy/fusion (ACDF) but with minimal data in the setting of corpectomy.
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]The aim of this study was to evaluate the fracture resistance of cervical lesion centered access cavity restored with short glass fibre reinforced resin materials in human mandibular premolars.
Clinical evaluation of a polyacid-modified resin composite (Dyract) in Class III cavities: 5-year results. [2006]This study evaluated the 5-year clinical performance of Dyract polyacid-modified resin composite material in Class III cavities.
The two-year clinical performance of esthetic restorative materials in noncarious cervical lesions. [2022]Materials used in restoration of cervical lesions include resin-modified glass ionomer cements, polyacid-modified resin-based composites and resin-based composites. In this study, the authors evaluated the clinical performance of these materials over a two-year period.
Long-term clinical evaluation of Dyract compomer in the restoration of non-caries cervical lesions: A 20-year retrospective study. [2021]The restoration of non-caries cervical lesions has long been a challenge. Until recently, compomers were the restorative materials of choice. The aim of this in-vivo study was to evaluate the long-term clinical performance of Dyract restorations in non-caries cervical lesions.
Technique on restoring sub-gingival cervical lesion. [2007]This article outlines an atraumatic isolation approach and a conservative instrumentation sequence, followed by use of a highly viscous, rapid-setting, capsulated glass ionomer cement to manage a difficult deep proximal-cervical Class V lesion.