aminectomy without or with dorsal fusion for cervical myeloradiculopathy: a (multi center randomized trial)

Conditions: cervical myelopathy
cervical spinal stenosis
10041543
10043413

Registration Number: NL-OMON30923

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

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
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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints<br /><br>Several score systems exist for grading the severity of cervical myelopathy.<br /><br>The modified Japanese Orthopedic functional score (Appendix A) evaluates four<br /><br>groups: the function of the arms, of the legs, the micturation, and the<br /><br>sensibility. It has the major advantage that it assesses motor function of the<br /><br>arms and of the legs separately, sensation, and evaluates urinary symptoms[6].<br /><br>Although it has been established that outcome after decompressive surgery<br /><br>reaches a plateau at six months postoperatively[7], the primary endpoint will<br /><br>be evaluated at one year postoperatively just to be sure.</p><br>

Secondary Outcome Measures