Surgical Management of Spinal Cord Injuries In Neck

NCT00475748 | Unknown Phase 2

• 2 other identifiers: H-28962Maryland DHMH# FHA07-004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Central Cord Syndrome; Spinal Cord Injury; Quadriparesis

Keywords

cervical spine; spinal cord; trauma; spinal cord injury; central cord syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• ASIA Motor Score

  12 months

Secondary Outcomes (1)

• 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

Interventions

Early and late surgery for traumatic central cord syndrome PROCEDURE

Surgical decompression of the spinal cord, either front, back or combined

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Children aged \<18
• Terminally ill patients, patients with non-survivable injuries and patients with demyelinating disease.
• Patients likely not to be able to appear for follow up.
• 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.
• Patients with acute disc herniation in need of urgent decompression.
• Patients with progressive neurologic worsening
• Patients with spinal cord injury without radiological abnormality (SCIWORA)
• Central cord syndrome in association with traumatic brain injury (GCS\<15)
• Patients with previous cervical spine injury and /or surgery. 10-ASIA (American Spinal Injury Association) grade A patients

Sponsors & Collaborators

• Maryland Department of Health and Mental Hygiene: lead
• University of Maryland, Baltimore: collaborator

Study Sites (1)

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Central Cord Syndrome; Spinal Cord Injuries; Quadriplegia; Wounds and Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bizhan Aarabi, M.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 17, 2007
• First Posted: May 21, 2007
• Study Start: May 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2010
• Last Updated: June 24, 2009

Record last verified: 2009-06

Locations

US (1)