Central Spinal Cord Syndrome Clinical Trial
Official 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).
See Above. Further information in this registration ( Randomized controlled trial (RCT), sample size etc) ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00476866 -
Intermittent Positive-Pressure Breathing Effects in Patients With High Spinal Cord Injury
|
N/A |