cervical herniated disc
Conditions
Interventions
Anterior discectomy with ceramic cages versus anterior discectomy with PEEK
cages.
Sponsors
Amedica Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age between 18 - 75 years. * Radicular signs and symptoms in one or both arms (i.e., pain, paraesthesiae or paresis in a specific nerve root distribution) or symptoms and signs of acute or chronic myelopathy. * At least 8 weeks prior conservative treatment (i.e., physical therapy, pain medication). * Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level (C3-C4 to C7-T1) in accordance with clinical signs and symptoms. * Written informed consent .
Exclusion criteria
Exclusion criteria: * Previous cervical surgery (either anterior or posterior). * Increased motion on dynamic studies (> 3 mm). * Severe segmental kyphosis of the involved disc level (> 7 degrees). * Patient cannot be imaged with MRI. * Neck pain only (without radicular or medullary symptoms). * Infection. * Metabolic and bone diseases (osteoporosis, severe osteopenia). * Neoplasma or trauma of the cervical spine. * Spinal anomaly (Klippel Feil, Bechterew, OPLL). * Severe mental or psychiatric disorder. * Inadequate Dutch language. * Planned (e)migration abroad in the year after inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neck Disability Index (NDI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Neckpain, armpain, patient's perceived recovery, fusion, EuroQol, re-operations and complications. | — |
Countries
Netherlands
Outcome results
None listed