Table 2.
Inclusion and exclusion criteria from Brazil PCM study.25
Inclusion criteria |
• 18–80 y old |
• Discogenic radiculopathy of the cervical spine, with radiculopathy symptoms in 1 or both arms; pain, paresthesias, or paralysis in a specific nerve root distribution |
• Involvement at 1, 2, 3, or 4 disc levels from C3 to T1 |
• Radiographically determined discogenic radiculopathy to include at least one of the following: |
○ Cervical spondylosis or cervical spondylitic myelopathy |
○ Disc herniation on CT or MRI |
○ Pseudarthrosis or failed prior attempted ACDF |
○ Failed cervical cages or arthroplasty |
• 6 wk conservative care |
Exclusion criteria |
• Prior disc space infection or osteomyelitis in the cervical spine |
• Previous trauma to the C3–C7 levels resulting in compression or bursting |
• Axial neck pain in the absence of other symptoms of radiculopathy |
• Osteoporosis, osteopenia, or other metabolic bone disease of the spine |
• Active malignancy or other spinal tumor |
• Acute cervical trauma or instability: no anterior subluxation > 3.5 mm on flexion-extension radiographs |
• Circulatory, cardiac, or pulmonary problems that could cause excessive surgical risk |
• Known or suspected metal allergy |
• Severe myelopathy to the extent that the patient is wheelchair bound |
• Mid-sagittal stenosis of < 8 mm, as measured by CT or MRI |
• Autoimmune disorders (eg, lupus, rheumatoid arthritis) |
• Psychosocial disorder (indicated by Waddell score > 3) |
• Morbid obesity, defined as body mass index > 40 or more than 100 lb over ideal body weight |
Abbreviations: ACDF, anterior cervical discectomy and fusion; CT, computed tomography; MRI, magnetic resonance imaging.