Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000145505
Ethics application status
Approved
Date submitted
27/04/2006
Date registered
27/04/2006
Date last updated
27/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Cervical Discoligamentous Injury Study
Scientific title
Correlation of Clinical and Radiographic Findings with Long Term Outcomes in Road Trauma Patients with Acute Cervical Discoligamentous Injury
Secondary ID [1] 280028 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Discoligamentous Injury 1114 0
Condition category
Condition code
Injuries and Accidents 1194 1194 0 0
Cervical (Cervix)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention
Intervention code [1] 1001 0
None
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1622 0
Physical and functional capacity assessed using NDI, HADS and Quebec Taskforce assessment forms
Timepoint [1] 1622 0
At 1, 6 and 12 months
Primary outcome [2] 1623 0
Acute cervical disc and/or ligament injury detected on MRI assessed using designated MRI reporting tool
Timepoint [2] 1623 0
During the period of initial hospital admission
Secondary outcome [1] 2909 0
Nil
Timepoint [1] 2909 0
No timepoint

Eligibility
Key inclusion criteria
Road trauma patients presenting with neck pain or altered conscious stateNo radiographic evidence of cervical fracture on plain film or CTCervical MRI.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Focal neurologic deficitEvidence of intoxicationPainful distracting injuryAltered mental status where GCS<9.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1308 0
Charities/Societies/Foundations
Name [1] 1308 0
Victorian Trauma Foundation
Country [1] 1308 0
Australia
Primary sponsor type
Hospital
Name
National Trauma Research Institute, The Alfred Hospital, Melbourne
Address
89 Commercial Road, Prahran, Victoria, Australia, 3181
Country
Australia
Secondary sponsor category [1] 1155 0
University
Name [1] 1155 0
Monash University Department of Epidemiology and Preventive Medicine
Address [1] 1155 0
89 Commercial Road, Prahran, Victoria, Australia, 3181
Country [1] 1155 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2636 0
The Alfred Hospital
Ethics committee address [1] 2636 0
Ethics committee country [1] 2636 0
Australia
Date submitted for ethics approval [1] 2636 0
Approval date [1] 2636 0
27/03/2006
Ethics approval number [1] 2636 0
10/06
Ethics committee name [2] 2637 0
Monash University
Ethics committee address [2] 2637 0
Ethics committee country [2] 2637 0
Australia
Date submitted for ethics approval [2] 2637 0
Approval date [2] 2637 0
24/04/2006
Ethics approval number [2] 2637 0
2006/299MC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35140 0
Address 35140 0
Country 35140 0
Phone 35140 0
Fax 35140 0
Email 35140 0
Contact person for public queries
Name 10190 0
Ms Helen Ackland
Address 10190 0
National Trauma Research Institute,
The Alfred Hospital,
89 Commercial Rd,
Prahran, Melbourne,VIC 3181.
Country 10190 0
Australia
Phone 10190 0
+61 03 9207 1543
Fax 10190 0
+61 03 9207 1811
Email 10190 0
h.ackland@alfred.org.au
Contact person for scientific queries
Name 1118 0
Ms Helen Ackland
Address 1118 0
National Trauma Research Institute
The Alfred Hospital
89 Commercial Rd
Prahran Melbourne VIC 3181
Country 1118 0
Australia
Phone 1118 0
+61 03 9207 1543
Fax 1118 0
+61 03 9207 1811
Email 1118 0
h.ackland@alfred.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.