Launch of the COSMIC trial
COSMIC is an acronym for Conservative Or Surgical Management of Incomplete Cervical cord syndrome. In September 2013 this study started in the Radboud University Medical Center in Nijmegen (Principal investigator: Dr. Ronald Bartels, head of the department). The main researcher is Eveline Brouwers.
The COSMIC study is designed because there is no consensus concerning the best treatment for patients presented with a traumatic central cord syndrome (CCS). Central cord syndrome is an acute cervical spinal cord injury which is characterized by disproportionately greater motor impairment in upper extremities when compared to lower extremities, and variable degree of sensory loss below the level of injury in combination with bladder dysfunction and urinary retention. This syndrome differs from that of a complete lesion, which is characterized by total loss of all sensation and movement below the level of the injury.
Although CCS is known as a (partial) self limiting disease, secondary neurological deterioration may occur due to the presence of edema or hemorrhage. In such cases, decompressive surgery is an option. However, surgery can be accompanied with complications while on the other hand spontaneous recovery may occur making surgery unneccessary. So the main question is what to do, operate or ‘see and wait’?
Patients with CCS will be randomized to the surgical or conservative (‘see and wait’) group. Patients in the surgical group will be operated within 24 hours after trauma. Follow up will be at 6 weeks, 12 weeks, 12 months and 24 months. During the follow up period functional outcome will be monitored using several questionnaires and physical examination. With the results of this study, we hope to find evidence for the best treatment for this group of patients.
For more information, please contact the office of the department of Neurosurgery in the Radboud University Medical Center and ask for Eveline Brouwers (phone number: +31 24 3616604).