Condition category
Injury, Occupational Diseases, Poisoning
Date applied
16/05/2007
Date assigned
06/06/2007
Last edited
06/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bizhan Aarabi

ORCID ID

Contact details

Department of Neurosurgery
University of Maryland School of Medicine
22 S Greene Street
Suite S-12-D
Baltimore
21201
United States of America
410-328-7371
baarabi@smail.umaryland.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

H-28962

Study information

Scientific title

Acronym

CCSS

Study hypothesis

In acute traumatic central cord syndrome, surgical decompression of the spinal cord within 5 days will result in more rapid motor recovery, than decompression 6 weeks following injury.

Ethics approval

Human Research Protection Office, Health Science Facility I (HSFI), School of Medicine University of Maryland (Baltimore, Maryland), approved on 14 May 2007.

Study design

Single center, prospective, randomized study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Traumatic Central Cord Syndrome

Intervention

30 patients (15 patients in each group) will undergo standard surgical decompression of spinal cord either within the first 5 days or at 6 weeks following spinal cord injury. Each of the 15 patients enrolled for late decompression will be kept in hard collar while in a rehabilitation facility and will undergo research related Computed Tomography (CT) studies at 3 weeks post admission. If interim imaging studies indicate glacial translation, earlier decompression and internal fixation may be considered. The choice of surgical technique for decompression is standard of treatment at the Shock Trauma Center. Standard surgical decompression of the spinal cord will be by a select group of Department of Neurosurgery staff with full familiarity with cervical spine surgical interventions.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

ASIA Motor score after 3 months.

Secondary outcome measures

1. Functional outcomes will be assessed at 3 and 12 months after injury by the following:
1.1. Functional Independence Measure (FIM)
1.2. Spinal Cord Independence Measure (SCIM)
1.3. Walking Index of Spinal Cord Injury (WISCI)
1.4. Quality of life (Short Form-36)
2. Degree of canal compromise, spinal cord compression and syrinx size, assessed after admission and on pre-operation and post-operation CT and MRI studies of early or late decompression (i.e. after 5 days or after 6 weeks)

Overall trial start date

15/04/2007

Overall trial end date

14/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. All adult patients (>17 years old) admitted to University of Maryland Medical System with traumatic central cord syndrome, canal compromise and evidence of spinal cord compression
2. Allen-Ferguson injury classification:
2.1. Distractive Extension Stage 1
2.2. Compressive Extension Stage 1
2.3. Vertical Compression Stage 1
2.4. Compressive Flexion Stage 1
3. Patient with American Spinal Injury Association (ASIA) level of injury from C4 to T1 inclusive
4. Patients with ASIA Impairment Grades B, C, and D/E
5. Pregnant and lactating women are also eligible for the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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:
4.1. Distractive Extension Stage 2, 3
4.2. Distractive Flexion Stages 1-4
4.3. Compressive Extension Stages 2-4
4.4. Vertical Compression Stages 2-4
4.5. Compressive Flexion Stages 2-4
4.6. 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 (Glasgow Coma Scale [GCS]<15)
9. Patients with previous cervical spine injury and /or surgery.
10. ASIA (American Spinal Injury Association) grade A patients

Recruitment start date

15/04/2007

Recruitment end date

14/04/2009

Locations

Countries of recruitment

United States of America

Trial participating centre

Department of Neurosurgery
Baltimore
21201
United States of America

Sponsor information

Organisation

Maryland Department of Health and Mental Hygiene (USA)

Sponsor details

201 W Preston Street
Baltimore
Maryland 21201
Baltimore
21201
United States of America
410-767-6743
PPatrick@dhmh.state.md.us

Sponsor type

Government

Website

http://maryland.gov/portal/server.pt?

Funders

Funder type

Government

Funder name

Maryland Department of Health and Mental Hygiene (DHMH). Grant Award Number FHA07-004. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes