Degenerative disc disease of the cervical spine Musculoskeletal Diseases Degenerative disc disease
Conditions
Interventions
Anterior cervical discectomy with fusion:
Group 1: Anterior single level cervical discectomy procedure with a Solis (non-resorbable PEEK) interbody cage device (no internal fixation)
Group 2: Anterior
Sponsors
Stryker SA (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to participate 2. Patient is male or female and between 18 and 70 years of age 3. Patient has clinical symptomatic myelopathy and/or radiculopathy 4. Based on clinical history, physical examination and radiographic evidence, pain interpreted as emanating between C3/4 and C6/7 5. No improvement of symptoms after at least three months of conservative treatment 6. Progressive neurological deficit despite conservative management irrespective of the duration 7. Evidence of degenerative changes between levels C3/4 and C6/7 (?spondylosis?) as shown on plain radiographs and/or computed tomography (CT) scan and/or magnetic resonance imaging (MRI). The pathology should be predominant on one level. Other levels may show degeneration, however, it should not be clinically necessary to operate on. 8. Use of autograft from the iliac crest or the spine is necessary 9. Capable of providing informed consent
Exclusion criteria
Exclusion criteria: 1. Previous cervical spine surgery at the symptomatic level to be operated on and previous cervical spine surgery during the last two years at other levels 2. Symptomatic degenerative disc disorder at more than one cervical level 3. Pregnancy or planning a pregnancy during the two year study 4. Ongoing severe psychiatric illness or mental retardation 5. Evidence of alcohol and/or drug abuse 6. Inability to complete the questionnaires 7. Local or general infection which could jeopardise the surgical objective 8. Extensive local inflammatory reactions 9. Proven or suspected hypersensitivity to materials 10. Immunosuppressive pathologies 11. Abnormal, immature or weak bone structure, insufficient quantity or quality or diseased bone that is incapable of supporting or stabilising the device 12. Severe pathologies of the airway, oesophagus, abnormal vascostructure or bypassing nerves 13. Other indications than degenerative spinal disorders including a metabolic bone disease, osteoporosis, infection, previous cervical spinal fracture, inflammatory process or neoplasm (confirmed by radiographs and/or dual energy x-ray absorptiometry [DEXA] scans and/or CT and/or MRI) 14. Excessive physical activity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Acquired fusion at six months 2. Subsidence and dynamic behaviour at every follow up 3. Absorption rate (for Solis RS only) at 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual Analogue Scale (VAS) score for arm and neck pain at every follow up (3, 6, 12, 24 months) 2. Neck Disability Index (NDI) at every follow up 3. Myelopathy Disability Index (MDI) at every follow up 4. Prolo Economic and Functional Scale at every follow up | — |
Countries
Denmark, France, Germany, Netherlands, Spain, United Kingdom
Outcome results
None listed