Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels

Launched by WILLIAM BEAUMONT HOSPITALS · Dec 30, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the use of a specific device called the Tritanium® C Anterior Cervical Cage to help patients with neck problems, such as herniated discs or degenerative disc disease. The goal is to see how well this device helps the spine heal after surgery called Anterior Cervical Discectomy and Fusion (ACDF), which involves removing damaged discs and fusing the bones together. The trial is open to individuals aged 18 and older who have symptoms like neck or arm pain and have tried other treatments for at least six weeks without success.

To participate, patients should be planning to undergo surgery on either one or two levels of their cervical spine, specifically between the second cervical vertebra (C2) and the first thoracic vertebra (T1). Participants can expect to be monitored for their recovery and asked to share how they feel after the procedure. It's important to note that certain medical conditions or previous surgeries may prevent someone from joining the trial, so potential participants should discuss their eligibility with their doctor. This study is currently recruiting, and all genders are welcome to apply.

Gender

ALL

Eligibility 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
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