Phase
Condition
Radiculopathy
Treatment
Tritanium C Anterior Cervical Cage
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 withincreasing signs and symptoms of cervical myelopathy or radiculopathy that mayrequire immediate intervention -
Exclusion
Exclusion Criteria:
- Any prior history of cervical fusion 2. Requires cervical fusion of more than twolevels or not contiguous levels 3. Acute cervical spine trauma requiring immediateintervention 4. BMI > 40 5. Active systemic bacterial or fungal infection orinfection at the operative site 6. History of vertebral fracture or osteoporoticfracture 7. Current treatment with chemotherapy, radiation, immunosuppression orchronic steroid therapy 8. History of osteoporosis, osteopenia, or osteomalacia thatwould contraindicate spinal surgery 9. Psychological or physical condition in theopinion of the investigator that would interfere with completing study participationincluding completion of patient reported outcomes 10. History of neurologicalcondition in the opinion of the investigator that may affect cervical spine functionand pain assessments 11. Subjects with a history of cancer must be disease free forat least 3 years; with the exception of squamous cell skin carcinoma 12. Pregnant,or plans on becoming pregnant 13. History of allergy to titanium
Study Design
Study Description
Connect with a study center
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan 48073
United StatesActive - Recruiting
William Beaumont Hospital
Royal Oak, Michigan 48073
United StatesSite Not Available
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