American Spinal Injury Association (ASIA) motor, functional and health related quality of life outcome in traumatic Central Cord Syndrome, a prospective randomized Study

ISRCTN	ISRCTN85867641
DOI	https://doi.org/10.1186/ISRCTN85867641
Secondary identifying numbers	H-28962

Submission date: 16/05/2007
Registration date: 06/06/2007
Last edited: 19/10/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Bizhan Aarabi
Scientific

Department of Neurosurgery
University of Maryland School of Medicine
22 S Greene Street
Suite S-12-D
Baltimore
21201
United States of America

Phone	410-328-7371
Email	baarabi@smail.umaryland.edu

Study information

Study design	Single center, prospective, randomized study.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	American Spinal Injury Association (ASIA) motor, functional and health related quality of life outcome in traumatic Central Cord Syndrome, a prospective randomized Study
Study 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(s)	Human Research Protection Office, Health Science Facility I (HSFI), School of Medicine University of Maryland (Baltimore, Maryland), approved on 14 May 2007.
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
Primary outcome measure	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 study start date	15/04/2007
Overall study end date	14/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	30
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 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

Study participating centre

Department of Neurosurgery

Baltimore
21201
United States of America

Sponsor information

Maryland Department of Health and Mental Hygiene (USA)
Government

201 W Preston Street
Baltimore
Maryland 21201
Baltimore
21201
United States of America

Phone	410-767-6743
Email	PPatrick@dhmh.state.md.us
Website	http://maryland.gov/portal/server.pt?
"ROR"	https://ror.org/02e1t6r96

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

19/10/2021: Proactive update review. No publications found. Search options exhausted.