cervical myelopathy cervical spinal stenosis
Conditions
Interventions
Surgical technique
Cervical laminectomy of the compressed levels is performed. Previous to the
laminectomy a dorsal fusion is done. Dorsal fusion includes lateral mass screws
from C2 to C6. In C2, C
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In - and exclusion criteria Patients with a minimal age of 60 years are included (Table 1). At neurologic examination myelopathic changes must be apparent. At magnetic resonance imaging, concordant stenotic alterations at the cervical level(s) must be present. At the plain sitting lateral radiograph a lordotic spine must be shown. The shape of the cervical spine is lordotic when the vertebral bodies of C3 to C6 are in front of a line drawn from a point of the posterior inferior part of C2 to a point at the posterior superior part of C7 (Figure 1). Only patients that sign the informed consent after some time of reflection (1 week) are included.
Exclusion criteria
Exclusion criteria: Exclusion Previous cervical surgery for myelopathic signs and symptoms Solely radiculopathy, or most important complaint Unable to undergo MRI Life expectancy less than 1 year Other diseases interfering with neurologic symptoms and signs, for example spinal cord glioma, thoracic herniated disc with spinal cord compression, multiple sclerosis etc. Rheumatoid arthritis Trauma to the neck in history Diseases interfering with rehabilitation, for example severe cardiac congestive disease. Participation in another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints Several score systems exist for grading the severity of cervical myelopathy. The modified Japanese Orthopedic functional score (Appendix A) evaluates four groups: the function of the arms, of the legs, the micturation, and the sensibility. It has the major advantage that it assesses motor function of the arms and of the legs separately, sensation, and evaluates urinary symptoms[6]. Although it has been established that outcome after decompressive surgery reaches a plateau at six months postoperatively[7], the primary endpoint will be evaluated at one year postoperatively just to be sure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints Since instrumentation is added in the fusion group, the costs will be higher. Otherwise it is assumed that a mean better recovery will take place in the fusion group. Therefore, the additional costs (nursing costs, auxillary supports, etc.) may be lower. A careful evaluation of the costs of the treatment related to the outcome is performed. To obtain a reliable insight in the costs the following will be noted in a kind of diary: hospitalisation, out - patient contacts, additional medication, house keeping support, instruments to support daily activities, e.g. walking, eating etcetera. Of each item the sort and amount will be recorded. Apart from the cost - effectiveness, the difference in the general quality of life will be evaluated. It is assumed that the quality of life of a laminectomy will improve after adding a fusion. This will be reflected in a difference of the SF - 36 score (Appendix B). SF - 36 Health Status Questionnaire is a widely-used generic health status. This instrument consists of eight subscales and two summary scales. On each scale higher scores indicate better outcomes. Scores can be compared with published age - and sex - matched general population or disease-specific norms[8]. Complications are separately registered. Complications related to the cervical myelopathy are postoperative hemorrhage, postoperative infection, temporary or permanent impairment of neurologic function, and kyphotic deformation of the cervical spine[4]. Complications related to adding lateral mass screws or/and pedicle screws are vertebral artery injury and temporary or permanent nerve root damage[4]. In order to prevent damage to the spinal cord , the instrumentation should be completed before the laminectomy. | — |
Countries
Netherlands
Outcome results
None listed