Surgical Management of Spinal Cord Injuries In Neck (CCSS)
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|ClinicalTrials.gov Identifier: NCT00475748|
Recruitment Status : Unknown
Verified June 2009 by Maryland Department of Health and Mental Hygiene.
Recruitment status was: Active, not recruiting
First Posted : May 21, 2007
Last Update Posted : June 24, 2009
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 or disease||Intervention/treatment||Phase|
|Central Cord Syndrome Spinal Cord Injury Quadriparesis||Procedure: Early and late surgery for traumatic central cord syndrome||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ASIA Motor, Functional and Health Related Quality of Life Outcome in Traumatic Central Cord Syndrome, a Prospective Randomized Study|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||May 2009|
|Estimated Study Completion Date :||May 2010|
- Procedure: Early and late surgery for traumatic central cord syndrome
Surgical decompression of the spinal cord, either front, back or combined
- 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 ]
- ASIA Motor Score [ Time Frame: 12 months ]
- 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 ]
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): NCT00475748
|United States, Maryland|
|University of Maryland Medical System|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Bizhan Aarabi, M.D.||University of Maryland, College Park|