Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels (STRYKER)
Cervical Disc Herniation, Cervical Disc Degeneration, Degenerative Disc Disease
About this trial
This is an interventional diagnostic trial for Cervical Disc Herniation focused on measuring Cervical Fusion, Cervical Disc Degeneration, Spinal Fusion, Tritanium® C Anterior Cervical Cage
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing a one or two (contiguous) level primary ACDF between C2-T1
- Able to provide consent
- ≥ 18 years of age and skeletally mature
- Diagnosis of symptomatic degenerative disc disease, including; myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, spondylosis, osteophyte complexes, and foraminal stenosis
- Neck pain and/or radicular symptoms with a baseline Visual Analog Scale score of ≥ 4 (0-10cm scale) for neck or arm pain
- Baseline Neck Disability score ≥ 20
- 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
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Sites / Locations
- William Beaumont HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Tritanium C Anterior Cervical Cage
50 subjects undergoing anterior cervical discectomy and fusion surgery using the Tritanium C Cervical Cage at one or two-levels