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Not listed Phase 2 Interventional

Surgical Management of Spinal Cord Injuries In Neck

ClinicalTrials.gov ID: NCT00475748

Public ClinicalTrials.gov record NCT00475748. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 6:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

ASIA Motor, Functional and Health Related Quality of Life Outcome in Traumatic Central Cord Syndrome, a Prospective Randomized Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00475748
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 2
Enrollment
30 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2007
Primary completion
Apr 30, 2009
Completion
Apr 30, 2010
Last update posted
Jun 23, 2009

2007 – 2010

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Maryland Medical System Baltimore Maryland 21201

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00475748, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 23, 2009 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00475748 live on ClinicalTrials.gov.

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