Table 2 Inclusion and exclusion criteria
Inclusion criteria | Age between 18 and 80 years |
Cervical spondylotic foraminal stenosis causing radiculopathy of C5, C6, or C7 and requiring decompression of ≤2 neuroforaminae | |
Radiculopathy is defined as pain, paralysis or paresthesia in corresponding nerve root distribution areas of C5, C6, or C7, and must include at least arm or shoulder pain with minimum of 30 mm on a 100 mm visual analog scale | |
Neck Disability Index score ≥30 out of 100 | |
Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or signs of nerve root compression in the face of conservative treatment | |
Spondylotic foraminal stenosis (determined by magnetic resonance imaging and computed tomography) at treatment level correlating to primary symptoms | |
Appropriate candidate for treatment using either of: | |
● Anterior approach via ventral discectomy and fusion | |
● Posterior approach via foraminotomy, as described by Frykholm | |
Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures | |
Personally signed and dated informed consent document prior to any study-related procedures, indicating that the patient has been informed of all pertinent aspects of the trial | |
Clinical exclusion criteria | Previous cervical spinal surgery at index level |
Lumbar or thoracic spinal disease to the extent that surgical consideration is probable or anticipated within 6 month after the cervical surgical treatment | |
Upper extremity degenerative joint diseases (that is, shoulder) to the extent that: | |
● Surgical consideration is likely or anticipated within 6 month after the cervical surgical treatment | |
● Resulting pain is chronic (>3 month) | |
Axial neck pain in the absence of other symptoms of radiculopathy justifying the need for surgical intervention | |
Myelopathy | |
Neoplasia as the source of symptoms | |
Fixed or permanent neurological deficit unrelated to the cervical disc disease | |
Disease or conditions that preclude accurate clinical evaluation (for example, neuromuscular disorders) | |
Active or chronic infection, systemic or local | |
Systemic disease, including HIV, AIDS, or hepatitis | |
Active malignancy defined as a history of any invasive malignancy, except non-melanoma skin cancer, unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for a minimum of 5 years | |
Paget’s disease, osteomalacia, or any other metabolic bone disease | |
Autoimmune disorder that impacts the musculoskeletal system (that is, lupus, rheumatoid arthritis, or ankylosing spondylitis) | |
Acute episode or major mental illness (psychosis, major affective disorder or schizophrenia) | |
Physical symptoms without a diagnosable medical condition to account for the symptoms, which might indicate symptoms of psychological rather than physical origin | |
Recent or current history of substance abuse (drugs, alcohol, narcotics, recreational drugs) | |
Anticipated long-term use of systemic steroid medications postoperatively | |
Radiological exclusion criteria | Symptomatic spondylotic foraminal stenosis, considered for surgical intervention, with contralateral asymptomatic spondylotic foraminal stenosis at the same level with equal or higher extent, as shown by computed tomography |
Cervical disc herniation or central canal stenosis causing radiculopathy or clinical myelopathy | |
Myelopathy, as shown by magnetic resonance imaging | |
Marked cervical instability on flexion or extension radiographs defined as: | |
● Translation >3 mm or | |
● Angulation >20° | |
Kyphotic segmental angulation >11° at treatment or adjacent levels | |
VARIA | |
Patient is currently pursuing personal litigation related to spinal diseases | |
Prisoner or ward of the state | |
Patient has used another investigational drug or device within the 30 days prior to surgery |