Spondylotic foraminal stenosis of the cervical spine Musculoskeletal Diseases Cervical spondylosis
Conditions
Interventions
Two surgical interventions will be compared:
1. Posterior foraminotomy
2. Anterior foraminotomy with fusion
One day prior to the surgical intervention patients are randomized to posterior or anterior
Sponsors
Innsbruck Medical University (Austria)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 18 - 80 years 2. Cervical spondylotic foraminal stenosis causing radiculopathy of C5 and/or C6 and/or C7 and requiring decompression of = 2 neuroforaminae 3. Radiculopathy is defined as pain, paralysis or paresthesia in corresponding nerve root distribution areas of C5 and/or C6 and/or C7, and must include at least arm/shoulder pain with minimum of 30 mm on 100 mm visual analogue scale (VAS) 4. Neck Disability Index (NDI) score = 30 out of 100 5. 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 6. Magnetic resonance imaging (MRI) and computerised tomography (CT) determined spondylotic foraminal stenosis at treatment level/levels that correlate to primary symptoms 7. Appropriate candidate for treatment using both an anterior approach via ventral discectomy and fusion or a posterior approach via foraminotomy as described by Frykholm 8. Psychosocially, mentally and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms and other study procedures 9. 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.
Exclusion criteria
Exclusion criteria: Clinical criteria: 1. Previous cervical spinal surgery at index level 2. Lumbar or thoracic spinal disease to the extent that surgical consideration is likely or anticipated within 6 months after the cervical surgical treatment 3. Upper extremity degenerative joint diseases (i.e. shoulder) to the extent that: 3.1. Surgical consideration is likely or anticipated within 6 months after the cervical surgical treatment 3.2. The resulting pain is chronic (>3 months) 4. Axial neck pain in the absence of other symptoms of radiculopathy justifying the need for surgical intervention 5. Myelopathy 6. Neoplasia as the source of symptoms 7. Fixed or permanent neurological deficit unrelated to the cervical disc disease 8. Disease or conditions that preclude accurate clinical evaluation (e.g. neuromuscular disorders) 9. Active or chronic infection, systemic or local 10. Systemic disease including HIV, AIDS, hepatitis 11. 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 12. Paget?s disease, osteomalacia, or any other metabolic bone disease (for osteoporosis see below) 13. Autoimmune disorder that impacts the musculoskeletal system (i.e. lupus, rheumatoid arthritis, ankylosing spondylitis) 14. Acute episode or major mental illness (psychosis, major affective disorder or schizophrenia) 15. Physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin 16. Recent or current history of substance abuse (drugs, alcohol, narcotics, recreational drugs) 17. Anticipated long-term use of systemic steroid medications postoperatively Radiological criteria: 1. A symptomatic spondylotic foraminal stenosis - considered for surgical intervention, with a contralateral asymptomatic spondylotic foraminal stenoses at the same level with equal or higher extent in the CT exams 2. Cervical disc herniation or central canal stenosis causing radiculopathy or clinical myelopathy 3. Myelopathy in the MRI exams 4. Marked cervical instability on flexion/extension radiographs defined as: Translation > 3mm and/or Angulation > 20° 5. Kyphotic segmental angulation >11° at treatment or adjacent levels Varia (Other): 1. Patient is currently pursuing personal litigation related to spinal diseases 2. Prisoner or ward of the state 3. Patient has used another investigational drug or device within the last 30 days prior to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neck Disability Index (NDI) at five years follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Core Outcome Measures Index (COMI) 2. Individual patient success at 12, 24, 36 and 60 months consisting of: 2.1. Improvement of at least 17 in the NDI (100 points) compared to baseline (adjustable according to results from own MCIC results for NDI) 2.2. Pain relief, as defined by =20 mm improvement on 100 mm VAS for arm/shoulder pain 2.3. Global outcome (1 or 2 on five-category Likert scale) 2.4. No opiates or opiate derivatives because of neck and/or arm pain 2.5. Absence of symptomatic device failure and re-operations at the index level 3. Pain relief, as defined by =20 mm improvement on 100 mm VAS for neck pain and arm/shoulder pain 4. Changes in physical and mental health defined as improvement of 15% in the overall score as captured by the SF-12v2 5. Modified Japanese Orthopedic Association (mJOA) score and Nurick score 6. Adjacent level degeneration: 6.1. By evidence of instability, defined as sagittal plane translation >3.5mm (20% of vertebral body - AP diameter) and/or sagittal plane rotation of >20° based on standing flexion/extension X-rays 6.2. By evidence of disc degeneration (Miyazaki grade = IV) and/or osteochondrosis (Modic change type I) on MRI 6.3. Radiographic classification (Walraevens 0-3) 6.4. By occurrence of operation because of adjacent level disease 7. Quantitative sensory testing 8. Segmental lordosis and overall cervical sagittal alignment 9. Operative time 10. Length of hospital stay 11. Pain medication usage (including epidural injections and nerve block injections) 12. Return to work 13. Worker's compensation 14. Direct and indirect societal costs | — |
Countries
Austria, Germany
Outcome results
None listed