Spinal Cord Injury Clinical Trial
— CCSSOfficial title:
ASIA Motor, Functional and Health Related Quality of Life Outcome in Traumatic Central Cord Syndrome, a Prospective Randomized Study
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.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | May 2010 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Medical System | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Maryland Department of Health and Mental Hygiene | University of Maryland |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | one year | No | |
Primary | ASIA Motor Score | 12 months | No | |
Secondary | 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. | One year | No |
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