Trial record 1 of 273 for:    Central Cord Syndrome
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Surgical Management of Spinal Cord Injuries In Neck (CCSS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Maryland Department of Health and Mental Hygiene.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Maryland
Information provided by:
Maryland Department of Health and Mental Hygiene
ClinicalTrials.gov Identifier:
NCT00475748
First received: May 17, 2007
Last updated: June 23, 2009
Last verified: June 2009
  Purpose

ABSTRACT/EXECUTIVE SUMMARY BACKGROUND, SIGNIFICANCE & RATIONALE: Between 10-20% of the more than 6000 cases of spinal cord injury seen annually in the North America have the clinical pattern of traumatic central cord syndrome (TCCS). These patients are usually older, most likely have sustained a fall, and have incomplete spinal cord injury characterized by dysesthetic and weak upper extremities. CT scan of the cervical spine in patients with TCCS often shows disc/osteophytes complex superimposed on degenerative or congenital spinal stenosis and MRI reveals signal changes at one or multiple skeletal segments. A minority of these patients suffer from fracture/subluxations, however, this group of patients are younger and have been involved in a more dynamic trauma. Since 1951, when Schneider et al reported this syndrome, controversy has dominated its surgical management. The current "Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries" recommendations are only at the level of options, since prospective outcome data are unavailable.

HYPOTHESIS: in acute traumatic central cord syndrome, surgical decompression of the spinal cord within five days will result in more rapid motor recovery, than decompression 6 weeks following injury. To test this hypothesis, we will pursue the following specific aims:

SPECIFIC AIM I: To compare American Spinal Injury Association (ASIA) Motor Scores after three months post injury in patients with central cord syndrome operated on within five days of injury to a similar group of patients operated on 6 weeks following injury.

SPECIFIC AIM II: To compare functional outcome, health related quality of life and posttraumatic syrinx size in patients with traumatic central cord syndrome operated on within five days to a similar group of patients operated on 6 weeks following injury.

DESIGN: Single center prospective randomized study. PROCEDURE: In a two-year period thirty patients with traumatic central cord syndrome and cord compression (15 patients in each group) will be randomized to undergo surgical decompression either within the first five days or at 6 weeks following spinal cord injury. ASIA motor, functional recovery and health related quality of life between the two groups will be compared at admission, discharge from rehab facility 3 months and 12 months after surgery.


Condition Intervention Phase
Central Cord Syndrome
Spinal Cord Injury
Quadriparesis
Procedure: Early and late surgery for traumatic central cord syndrome
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ASIA Motor, Functional and Health Related Quality of Life Outcome in Traumatic Central Cord Syndrome, a Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Maryland Department of Health and Mental Hygiene:

Primary Outcome Measures:
  • To compare ASIA Motor score after 3 months in patients with central cord syndrome operated on within five days to a similar group of patients operated on 6 weeks following injury. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • ASIA Motor Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare functional outcome and quality of life at 3 and 12 months after injury 2) To compare the degree of canal compromise, spinal cord compression and syrinx size with outcome in patients with TCCS. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2007
Estimated Study Completion Date: May 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Early and late surgery for traumatic central cord syndrome
    Surgical decompression of the spinal cord, either front, back or combined
  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. All adult patients (>17 years old) admitted to University of Maryland Medical System with traumatic central cord syndrome and evidence of spinal cord compression.
  2. Allen-Ferguson Injuries: Distractive Extension Stages 1, Compressive Extension Stage 1, Vertical Compression Stages 1, Compressive Flexion Stage 1.
  3. Patient with ASIA (American Spinal Injury Association) level of injury from C4 to T1 inclusive
  4. Patients with ASIA (American Spinal Injury Association) Impairment Grades B, C, and D/E
  5. Pregnant women 6-Lactating women

Exclusion Criteria:

  1. Children aged <18
  2. Terminally ill patients, patients with non-survivable injuries and patients with demyelinating disease.
  3. Patients likely not to be able to appear for follow up.
  4. Allen-Ferguson Injuries: Distractive Extension Stage 2, 3, Distractive Flexion Stages 1-4, Compressive Extension Stages 2-4, Vertical Compression Stages 2-4, Compressive Flexion Stages 2-4, Vertical Distraction Injuries.
  5. Patients with acute disc herniation in need of urgent decompression.
  6. Patients with progressive neurologic worsening
  7. Patients with spinal cord injury without radiological abnormality (SCIWORA)
  8. Central cord syndrome in association with traumatic brain injury (GCS<15)
  9. Patients with previous cervical spine injury and /or surgery. 10-ASIA (American Spinal Injury Association) grade A patients
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00475748

Locations
United States, Maryland
University of Maryland Medical System
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Maryland Department of Health and Mental Hygiene
University of Maryland
Investigators
Principal Investigator: Bizhan Aarabi, M.D. University of Maryland
  More Information

No publications provided

Responsible Party: Bizhan Aarabi, University of Maryland
ClinicalTrials.gov Identifier: NCT00475748     History of Changes
Other Study ID Numbers: H-28962, Maryland DHMH# FHA07-004
Study First Received: May 17, 2007
Last Updated: June 23, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Maryland Department of Health and Mental Hygiene:
cervical spine
spinal cord
trauma
spinal cord injury
central cord syndrome

Additional relevant MeSH terms:
Retinitis Pigmentosa
Spinal Cord Injuries
Syndrome
Central Cord Syndrome
Spinal Cord Diseases
Central Nervous System Diseases
Eye Diseases, Hereditary
Eye Diseases
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Genetic Diseases, Inborn
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014