Central Spinal Cord Syndrome Clinical Trial
— COSMICOfficial title:
COSMIC: Conservative or Early Surgical Management of Incomplete Cervical Cord Syndrome Without Spinal Instability. Randomized Controlled Trial
Traumatic Central Cord Syndrome (TCCS) was until recent recognized as a separate clinical
entity. The most characteristic feature is the disproportionate more motor impairment of the
arms and especially the hands than the legs, bladder dysfunction and sensory.
Recently, it has been shown that the distinction of TCCS with an incomplete cervical spinal
cord lesion (ICSCL) is artificial. It is the most frequent incomplete traumatic spinal cord
lesion. It accounts for up to 70 % of all incomplete cervical spinal cord lesions. The exact
incidence is not known.
Uncertainty about the treatment 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. It 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 effect modification related to the mechanism
of trauma, this study will focus on ICSCL in patients without fracture or instability of the
cervical spine on radiological examination. Also the problem of crossover from the
conservative group to the surgical one due to the nature of spinal instability will be
reduced.
Goal of the study: To compare the efficacy of early decompressive surgery to improve
functional outcome in patients with ICSCL without a fracture or instability of the cervical
spine compared to those receiving conservative treatment.
Definition of ICSCL in this study: ICSCL is 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. An overt sequestrated
herniated disc should not be present since this will always necessitate immediate surgery.
Involvement of the cervical spinal cord should be established at physical examination
(symptomatic arm or hand dysfunction is obligatory).
Status | Terminated |
Enrollment | 1 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - all patients with a history of a traumatic event to the cervical spine fulfilling the criteria of incomplete cervical spinal cord lesion. - Exclusion Criteria: - cognitive 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud University Nijmegen Medical Center | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dutch translation of mJOA | functional outcome at two years measured by Dutch translation of mJOA | two years post-injury | No |
Secondary | DASH | arm/hand function assessed by the disability of the arm, shoulder and hand questionnaire (DASH) | two years post-injury | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00476866 -
Intermittent Positive-Pressure Breathing Effects in Patients With High Spinal Cord Injury
|
N/A |