Comparing Surgical Decompression Versus Conservative Treatment in Incomplete Spinal Cord Injury (COSMIC)
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Purpose
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 | Intervention |
|---|---|
|
Central Spinal Cord Syndrome |
Procedure: Surgical decompression Procedure: Conservative treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | COSMIC: Conservative or Early Surgical Management of Incomplete Cervical Cord Syndrome Without Spinal Instability. Randomized Controlled Trial |
- Dutch translation of mJOA [ Time Frame: two years post-injury ] [ Designated as safety issue: No ]functional outcome at two years measured by Dutch translation of mJOA
- DASH [ Time Frame: two years post-injury ] [ Designated as safety issue: No ]arm/hand function assessed by the disability of the arm, shoulder and hand questionnaire (DASH)
| Estimated Enrollment: | 72 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
See Above. Further information in this registration ( RCT, sample size etc)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- all patients with a history of a traumatic event to the cervical spine fulfilling the criteria of ICSCL. -
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
Contacts and Locations| Contact: Ronald Bartels, M.D., Ph.D. | +31 24 3615200 | r.bartels@nch.umcn.nl |
| Netherlands | |
| Radboud University Nijmegen Medical Centre | Not yet recruiting |
| Nijmegen, Gelderland, Netherlands, 6500 HB | |
| Principal Investigator: Ronald Bartels, M.D.,Ph.D. | |
| Principal Investigator: | Ronald Bartels, M.D.,Ph.D. | Radboud University |
More Information
No publications provided by Radboud University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ronald Bartels,M.D.,Ph.D. Chairman Dpt Neurosurgery, Radboud University Nijmegen Medical Centre |
| ClinicalTrials.gov Identifier: | NCT01367405 History of Changes |
| Other Study ID Numbers: | NL36977.091.11 |
| Study First Received: | June 6, 2011 |
| Last Updated: | August 10, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
Surgical decompression conservative treatment incomplete spinal cord lesion recovery |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Central Cord Syndrome Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013