Surgery using Tritanium® C Cage for cervical disc issues
Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels: A Clinical And Radiographic Analysis Pilot Study
This study tests if a new type of cervical cage can help people with neck disc problems feel better and recover after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | William Beaumont Hospitals Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Royal Oak, Michigan) |
| Trial ID | NCT04214535 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the effectiveness of the Stryker Tritanium® C Anterior Cervical Cage in patients undergoing anterior cervical discectomy and fusion (ACDF) for one or two contiguous levels of the cervical spine. It focuses on individuals diagnosed with symptomatic degenerative disc disease, assessing fusion status and patient-reported outcomes over a follow-up period of up to 24 months. Participants will be monitored through standard care protocols, including imaging studies to determine successful fusion and symptom relief.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with symptomatic degenerative disc disease requiring surgical intervention at one or two contiguous cervical levels.
Not a fit: Patients with prior cervical fusion or those requiring more than two levels of fusion may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and quality of life for patients with cervical disc degeneration.
How similar studies have performed: Other studies have shown positive outcomes with similar surgical approaches, indicating potential for success with this method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients undergoing a one or two (contiguous) level primary ACDF between C2-T1 2. Able to provide consent 3. ≥ 18 years of age and skeletally mature 4. Diagnosis of symptomatic degenerative disc disease, including; myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, spondylosis, osteophyte complexes, and foraminal stenosis 5. Neck pain and/or radicular symptoms with a baseline Visual Analog Scale score of ≥ 4 (0-10cm scale) for neck or arm pain 6. Baseline Neck Disability score ≥ 20 7. Had at least 6-weeks of conservative non-operative treatment and/or presents with increasing signs and symptoms of cervical myelopathy or radiculopathy that may require immediate intervention - Exclusion Criteria: 1. Any prior history of cervical fusion 2. Requires cervical fusion of more than two levels or not contiguous levels 3. Acute cervical spine trauma requiring immediate intervention 4. BMI \> 40 5. Active systemic bacterial or fungal infection or infection at the operative site 6. History of vertebral fracture or osteoporotic fracture 7. Current treatment with chemotherapy, radiation, immunosuppression or chronic steroid therapy 8. History of osteoporosis, osteopenia, or osteomalacia that would contraindicate spinal surgery 9. Psychological or physical condition in the opinion of the investigator that would interfere with completing study participation including completion of patient reported outcomes 10. History of neurological condition in the opinion of the investigator that may affect cervical spine function and pain assessments 11. Subjects with a history of cancer must be disease free for at least 3 years; with the exception of squamous cell skin carcinoma 12. Pregnant, or plans on becoming pregnant 13. History of allergy to titanium -
Where this trial is running
Royal Oak, Michigan
- Corewell Health William Beaumont University Hospital — Royal Oak, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Jad G Khalil, MD — Beaumont Health
- Study coordinator: Grace San Agustin, RN
- Email: grace.sanagustin@corewellhealth.org
- Phone: 248-551-6679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.