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:
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Conditions: Cervical Disc Disease
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Age: Between 18 - 69 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- 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.
- Subjects who have symptomatic cervical disc disease (SCDD) at two contiguous levels from C3 to C7.
- 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.
- Subjects wiht a NDI Score of >30%.
- 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.
- Subjects with appropriate for treatment using an anterior surgical approach
- Subjects who are reported to be medically cleared for surgery.
- Physically and mentally able and willing to comply with the Protocol
- Subjects who can provide written informed consent
- 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:
You may not be eligible for this study if the following are true:
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- Subjects with an active systemic infection or infection at the operative site
- Subjects with history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C.
- 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
- Subjects who has previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
- Subjects who have had any prior spine surgery at the operative level(s).
- Subjects who have had a prior cervical TDR or fusion procedure at any level.
- Subjects with axial neck pain in the absence of other symptoms of radiculopathy or myelopathy withradiculopathy justifying the need for surgical intervention
- 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.
- Subjects who have radiographic confirmation of severe facet joint disease or degeneration at any level.
- Subjects who has osteoporosis or is at increased risk of osteoporosis
- Subjects who have Paget’s disease of bone, osteomalacia, or any other metabolic bone disease other than osteoporosis
- Subjects who have active malignancy
- Subjects with Symptomatic Cervical Disc Disease or significant cervical spondylosis
- Subjects who has marked cervical instability on resting (neutral) lateral or flexion-extension radiographs
- Subjects who have known allergies to cobalt, chromium, molybdenum, titanium, nickel, or polyethylene.
- Subjects who has segmental angulation of greater than 11° at treatment or adjacent levels.
- Subjects who are currently pregnant or breastfeeding
- Subjects who has rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system.
- Subjects with congenital bony and/or spinal cord abnormalities that affect spinal stability
- Subjects with diseases or conditions that would preclude accurate clinical evaluation
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.