Comparing Surgical Decompression Versus Conservative Treatment in Incomplete Spinal Cord Injury (COSMIC)
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|ClinicalTrials.gov Identifier: NCT01367405|
Recruitment Status : Terminated (only 1 inclusion in 1.5 years due to strict exclusion criteria)
First Posted : June 7, 2011
Last Update Posted : October 13, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Central Spinal Cord Syndrome||Procedure: Surgical decompression Procedure: Conservative treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||COSMIC: Conservative or Early Surgical Management of Incomplete Cervical Cord Syndrome Without Spinal Instability. Randomized Controlled Trial|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: surgical decompression
surgical decompression within 24 hours post-injury
Procedure: Surgical decompression
Surgical decompression within 24 hour postinjury
Active Comparator: Conservative treatment
Normal conservative treatment without surgical intervention
Procedure: Conservative treatment
Usual conservative treatment without surgery
- Dutch translation of mJOA [ Time Frame: two years post-injury ]functional outcome at two years measured by Dutch translation of mJOA
- DASH [ Time Frame: two years post-injury ]arm/hand function assessed by the disability of the arm, shoulder and hand questionnaire (DASH)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367405
|Radboud University Nijmegen Medical Center|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Principal Investigator:||Ronald Bartels, M.D.,Ph.D.||Radboud University|