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Sponsored by: |
Maryland Department of Health and Mental Hygiene |
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Information provided by: | Maryland Department of Health and Mental Hygiene |
ClinicalTrials.gov Identifier: | NCT00475748 |
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 |
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Central Cord Syndrome Spinal Cord Injury Quadriparesis |
Procedure: Early and late surgery for traumatic central cord syndrome |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | ASIA Motor, Functional and Health Related Quality of Life Outcome in Traumatic Central Cord Syndrome, a Prospective Randomized Study |
Estimated Enrollment: | 30 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2009 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bizhan Aarabi, M.D. | 410-328-7371 | baarabi@smail.umaryland.edu |
Contact: Charlene Aldrich, RN | 410-328-5332 | caldrich@smail.umaryland.edu |
United States, Maryland | |
University of Maryland Medical System | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Bizhan Aarabi, M.D. 410-328-7371 baarabi@smail.umaryland.edu | |
Contact: Charlene Aldrich, RN 410-328-5332 caldrich@smail.umaryland.edu | |
Principal Investigator: Bizhan Aarabi, M.D |
Principal Investigator: | Bizhan Aarabi, M.D. | University of Maryland School of Medicine |
Study ID Numbers: | H-28962, Maryland DHMH# FHA07-004 |
Study First Received: | May 17, 2007 |
Last Updated: | May 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00475748 History of Changes |
Health Authority: | United States: Institutional Review Board |
cervical spine spinal cord trauma spinal cord injury central cord syndrome |
Paralysis Signs and Symptoms Spinal Cord Injuries Spinal Cord Diseases Wounds and Injuries Quality of Life |
Neurologic Manifestations Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System Quadriplegia Central Cord Syndrome |
Disease Spinal Cord Diseases Nervous System Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Quadriplegia Central Cord Syndrome |
Trauma, Nervous System Paralysis Signs and Symptoms Spinal Cord Injuries Pathologic Processes Syndrome Neurologic Manifestations |