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Comparing Surgical Decompression Versus Conservative Treatment in Incomplete Spinal Cord Injury (COSMIC)

This study has been terminated.
(only 1 inclusion in 1.5 years due to strict exclusion criteria)
ClinicalTrials.gov Identifier:
First Posted: June 7, 2011
Last Update Posted: October 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Radboud University

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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COSMIC: Conservative or Early Surgical Management of Incomplete Cervical Cord Syndrome Without Spinal Instability. Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Dutch translation of mJOA [ Time Frame: two years post-injury ]
    functional outcome at two years measured by Dutch translation of mJOA

Secondary Outcome Measures:
  • DASH [ Time Frame: two years post-injury ]
    arm/hand function assessed by the disability of the arm, shoulder and hand questionnaire (DASH)

Enrollment: 1
Study Start Date: October 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (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 ( Randomized controlled trial (RCT), sample size etc)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

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
Sponsors and Collaborators
Radboud University
Principal Investigator: Ronald Bartels, M.D.,Ph.D. Radboud University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01367405     History of Changes
Other Study ID Numbers: NL36977.091.11
First Submitted: June 6, 2011
First Posted: June 7, 2011
Last Update Posted: October 13, 2016
Last Verified: November 2013

Keywords provided by Radboud University:
Surgical decompression
conservative treatment
incomplete spinal cord lesion

Additional relevant MeSH terms:
Central Cord Syndrome
Pathologic Processes
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries