Trial record 3 of 275 for:    Central Cord Syndrome

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01367405
First received: June 6, 2011
Last updated: November 18, 2013
Last verified: November 2013
  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

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 ] [ Designated as safety issue: No ]
    functional outcome at two years measured by Dutch translation of mJOA


Secondary Outcome Measures:
  • 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: October 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367405

Contacts
Contact: Ronald Bartels, M.D., Ph.D. +31 24 3615200 r.bartels@nch.umcn.nl

Locations
Netherlands
Radboud University Nijmegen Medical Center Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: Ronald HM Bartels, MD PhD       ronald.bartels@radboudumc.nl   
Principal Investigator: Ronald Bartels, M.D.,Ph.D.         
Sponsors and Collaborators
Radboud University
Investigators
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: Radboud University
ClinicalTrials.gov Identifier: NCT01367405     History of Changes
Other Study ID Numbers: NL36977.091.11
Study First Received: June 6, 2011
Last Updated: November 18, 2013
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:
Syndrome
Central Cord Syndrome
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Neural Tube Defects
Disease
Pathologic Processes
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Nervous System Malformations
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 19, 2014