A Multi-Center Prospective Randomized Controlled Trial Comparing the Safety and Effectiveness of prodisc C SK and prodisc C Vivo to Mobi-C Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Cervical Disc Disease
  • Age: Between 18 Year(s) - 69 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects with diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:
      • Neck and/or arm pain (at least 30 mm on the 100 mm visual analogue scale [VAS] scale).
      • Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.
      • Abnormal sensation including hyperesthesia or hypoesthesia; and/or
      • Abnormal reflexes.
    2. Subjects who have symptomatic cervical disc disease (SCDD) at two contiguous levels from C3 to C7.
    3. Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:
      • Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc.
      • Degenerative spondylosis on CT or MRI.
      • Disc herniation on CT or MRI.
    4. Subjects wiht a NDI Score of >30%.
    5. Subjects who are unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
      • Approximately six weeks from radiculopathy or myelopathy with radiculopathy symptom onset; or
      • Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative, conservative treatment; or
      • Sooner than 6 weeks for worsening symptoms of neurologic compromise.
    6. Subjects with appropriate for treatment using an anterior surgical approach
    7. Subjects who are reported to be medically cleared for surgery.
    8. Physically and mentally able and willing to comply with the Protocol
    9. Subjects who can provide written informed consent

You may not be eligible for this study if the following are true:

    1. Subjects with an active systemic infection or infection at the operative site
    2. Subjects with history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C.
    3. Subjects who have more than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic “spontaneous” fusions
    4. Subjects who has previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
    5. Subjects who have had any prior spine surgery at the operative level(s).
    6. Subjects who have had a prior cervical TDR or fusion procedure at any level.
    7. Subjects with axial neck pain in the absence of other symptoms of radiculopathy or myelopathy withradiculopathy justifying the need for surgical intervention
    8. Subjects who has disc height less than 3 mm as measured from the center of the disc in a neutral position and disc height less than 20% of the anterior-posterior width of the inferior vertebral body.
    9. Subjects who have radiographic confirmation of severe facet joint disease or degeneration at any level.
    10. Subjects who has osteoporosis or is at increased risk of osteoporosis
    11. Subjects who have Paget’s disease of bone, osteomalacia, or any other metabolic bone disease other than osteoporosis
    12. Subjects who have active malignancy
    13. Subjects with Symptomatic Cervical Disc Disease or significant cervical spondylosis
    14. Subjects who has marked cervical instability on resting (neutral) lateral or flexion-extension radiographs
    15. Subjects who have known allergies to cobalt, chromium, molybdenum, titanium, nickel, or polyethylene.
    16. Subjects who has segmental angulation of greater than 11° at treatment or adjacent levels.
    17. Subjects who are currently pregnant or breastfeeding
    18. Subjects who has rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system.
    19. Subjects with congenital bony and/or spinal cord abnormalities that affect spinal stability
    20. Subjects with diseases or conditions that would preclude accurate clinical evaluation

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