To compare the efficacy of early decompressive surgery to improve functional outcome in patients with cevical incomplete cord lesion without a fracture or instability of the cervical spine compared to those receiving conservative treatment.
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: functional outcome at two years measured by Dutch translation
of mJOA.
Secondary outcome
Secondary outcomes: motor and sensory scores according to the ASIA standards at
six weeks, 12 weeks, 12 months, stay at a high care department (medium care,
intensive care), stay at the hospital, complication rate, mortality rate, sort
of rehabilitation and kind of rehabilitation, quality of life, and arm/hand
function assessed by the disability of the arm, shoulder and hand questionnaire
(DASH),SCIM III .
Background summary
Incomplete spinal cord lesion due to a cervical spine trauma is frequently
encountered. It may happen without radiological signs of cervical instability.
Uncertainty about the treatment still exists. A good recovery has been
described after conservative treatment. Conservative treatment was usually
considered when a fracture or dislocation of the spine were absent. Incomplete
spinal cord lesion is often seen in hyperextension trauma in the elderly with
degenerative spondylotic stenotic cervical spine. However, some reports suggest
a better outcome after surgical decompression. Randomized trials have not been
performed. To avoid discussion about possible confounding or effectmodification
related to the mechanism of trauma, this study will focus on incomplete cord
lesion in patients without fracture or instability of the cervical spine on
radiological examination.
Study objective
To compare the efficacy of early decompressive surgery to improve functional
outcome in patients with cevical incomplete cord lesion without a fracture or
instability of the cervical spine compared to those receiving conservative
treatment.
Study design
The study has been designed as a multi center, open, randomized controlled
trial. Participating centers should have adequate experience with the treatment
of patients with spinal cord trauma and neurosurgical facilities should be
available on a 24 hours a day basis. All primary analyses will be performed on
an intention to treat basis, but if considered useful, additional per protocol
analyses will be performed.
Intervention
Conservative treatment or surgical decompression of the spinal cord
Study burden and risks
N/A
Geert Groote Plein-Zuid 10
Nijmegen 6525 GA
NL
Geert Groote Plein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36977.091.11 |