Enrollment in the two-level Mobi-C® trial arm was limited to subjects who met the following inclusion criteria.
- Age 18-69 years.
- Diagnosis of radiculopathy or myeloradiculopathy 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:
Symptomatic 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:
- 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.
NDI Score of ≥ 15/50 or ≥ 30%.
Unresponsive to nonoperative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
- 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.
Appropriate for treatment using an anterior surgical approach, including having no prior surgery at the operative level and no prior cervical fusion procedure at any level.
Reported to be medically cleared for surgery.
Reported to be 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.
Written informed consent provided by subject or subject’s legally authorized representative.
Willingness to discontinue all use of non-steroidal anti-inflammatory drugs (NSAIDs) from one week before surgery until 3 months after surgery.
- Approximately six weeks from radiculopathy or myeloradiculopathy symptom onset; or
- Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued nonoperative conservative treatment