COSMIC: Conservative or early Surgical Management of Incomplete cervical Cord syndrome without spinal instability. Randomized controlled trial
Completed
- Conditions
- spinal cord lesion1004154310019190
- Registration Number
- NL-OMON39722
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
all patients with a history of a traumatic event to the cervical spine with an incomplete spinal cord lesion due to a cervical spine trauma. At CT scanning with reconstruction and at MRI signs are not seen that could indicate a fracture of the cervical spine or instability.
Exclusion Criteria
ASIA A at neurologic examination,mental impairments, a preexistent neurologic deficit of arms and/or legs, psychiatric illness, significant comorbidity interfering with the indication to perform surgery or not, use of anticoagulating drugs, addiction to drugs or alcohol (more than five units daily), not speaking Dutch language fluently, not willing to participate, participating in another trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome: functional outcome at two years measured by Dutch translation<br /><br>of mJOA. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes: motor and sensory scores according to the ASIA standards at<br /><br>six weeks, 12 weeks, 12 months, stay at a high care department (medium care,<br /><br>intensive care), stay at the hospital, complication rate, mortality rate, sort<br /><br>of rehabilitation and kind of rehabilitation, quality of life, and arm/hand<br /><br>function assessed by the disability of the arm, shoulder and hand questionnaire<br /><br>(DASH),SCIM III .</p><br>