Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Treat Multilevel DDD (FUSE)

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring cervical spine, myelopathy, radiculopathy, cervical spine fusion, circumferential cervical fusion, degenerative disease Read More

Inclusion Criteria:

1. Age 18-80 years (Skeletally Mature)
2. Indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 3 contiguous levels
3. NDI Score of ≥15/50
4. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics)
5. Reported to be medically cleared for surgery
6. Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol.
7. Written informed consent provided by subject

Exclusion Criteria:

1. Body Mass Index (BMI) greater than 40 kg/m2
2. Active systemic infection or infection at the operative site
3. History of or anticipated treatment for active systemic infection, including HIV or Hepatitis C
4. Previous trauma to the C3 to C7 levels resulting in significant bony or disco- ligamentous cervical spine injury that may prevent device placements
5. A prior spine surgery or pseudoarthrosis at the operative levels
6. Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention
7. Symptomatic DDD or significant cervical spondylosis at more than three levels
8. Diagnosis of spondylolisthesis, grade >2
9. Overt (Segmental) instability measured as a movement on dynamic flex/ext x-rays >3.5 mm
10. Congenital bony and/or spinal cord abnormalities that affect spinal stability
11. Diagnosis of Paget's disease, osteomalacia or any other metabolic bone disease other than osteoporosis
12. Osteoporosis, defined as either the SCORE or MORES ≥ 6 and a DEXA bone density measured T-score of ≤ -2.5
13. Active malignancy or a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and without clinical signs or symptoms of the malignancy for at least five years
14. Has an uncontrolled seizure disorder
15. Use of epidural steroids within 14 days prior to surgery
16. A concomitant condition requiring daily, high-dose oral and/or inhaled steroids
17. Known allergy to titanium (Ti).
18. Fixed or permanent neurologic deficit related to the target treatment levels that cannot be improved with surgical decompression
19. Has, in the Investigator's opinion, any disease or condition that would preclude accurate clinical evaluation (e.g. neuromuscular disorders).
20. Is pregnant or nursing at time of screening, or with plans to become pregnant within the next three years.
21. A current or recent history (≤ 1 year prior to screening) of substance abuse (alcoholism and/or narcotic addiction) that required treatment.
22. Long term use (>6 months) of opioids (max. daily amount=120 mg morphine equivalents).
23. A mental illness or belongs to a vulnerable population, as determined by the investigator (e.g., prisoner or developmentally disabled), that would compromise ability to provide informed consent or compliance with follow-up requirements.
24. Any other condition or anatomy (e.g. fused facet) that makes posterior fusion treatment infeasible
25. Use of any other investigational drug or medical device within the last 30 days prior to surgery.
26. A pending personal litigation relating to spinal injury (worker's compensation is not exclusionary).
27. Anticipated or potential relocation greater than 50 miles that may interfere with completion of follow-up examinations.