Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001261101
Ethics application status
Approved
Date submitted
21/08/2019
Date registered
12/09/2019
Date last updated
15/06/2021
Date data sharing statement initially provided
12/09/2019
Date results information initially provided
12/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A retrospective study on the utility of neck MRI scans following normal CT and Xray
Scientific title
A retrospective analysis of the utility of cervical spine MRI in patients with normal CT and plain radiographs
Secondary ID [1] 299045 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blunt cervical trauma 314061 0
Condition category
Condition code
Injuries and Accidents 312447 312447 0 0
Other injuries and accidents
Injuries and Accidents 312448 312448 0 0
Fractures
Musculoskeletal 312572 312572 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Following acute blunt cervical trauma, spinal cord injury carries a heavy disease burden. With such high morbidity at stake, it is crucial not to miss the diagnosis of cervical spine injuries in order to prevent spinal cord injuries. Establishment of cervical spine clearance is a common clinical conundrum encountered by health care professionals. CT has superseded plain radiographs as the primary screening modality. Nonetheless, a proportion of cervical injuries are caused by soft tissue injuries which may not be detected on CT scan alone. In patients with normal CT scans and plain radiographs who have persistent neck pain, focal neurology or are clinically unassessable due to altered mental status, there is ongoing debate regarding the reliability of CT scans in excluding cervical injuries versus the need for further imaging with MRI. Albeit frequently performed, the utility and cost-effectiveness of MRI remains an ongoing debate and requires further validation. Thus, the primary objective of this study was to determine the incidence of additional findings on MRI imaging that were not previously detected on CT scan.

A single-centre, retrospective analysis was conducted at Tertiary care, Level 1 Trauma Centre in Western Australia using keyword searches on the PACS-RIS (Picture Archiving and Communication System- Radiology Information System) imaging database including the following terms: “cervical”, “injury”, “rupture”, “sprain”, “strain”, “tear”, “tenderness”. The search included scans performed from 1st January 2004 to 2nd October 2017. No participant involvement was required in this study. Patients who had a normal CT scan or plain radiographs and subsequently underwent an MRI scan to rule out potential cervical injuries were included in the study. Reports of the MRI scans were obtained and the incidence of abnormalities found on MRI was evaluated as the primary endpoint. The MRI must be performed within the same admission as the acute injury.

The secondary endpoint was the percentage of patients with normal CT scans or plain radiographs whose management was altered following additional abnormalities found on MRI. To quantify this, management of patients was followed up from discharge summaries, inpatient notes and/or outpatient clinic notes from the medical records.
Intervention code [1] 315318 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321098 0
Incidence of additional findings (e.g. ligamentous injury, vertebral disc injury, dural haematoma, soft tissue swelling, cervical cord injury and joint effusion) on MRI imaging that were not previously detected on CT scan.
Timepoint [1] 321098 0
MRI must have occurred during the same admission of the acute injury (no specific timepoint)
Secondary outcome [1] 373980 0
Change in management of patients with suspected cervical injuries and normal CT scans or plain radiographs post MRI as determined by the treating physician i.e. spinally cleared, conservative management or surgical management
Timepoint [1] 373980 0
The management pertains to the outcome of the admission for the acute injury. (no specific timepoint)

Eligibility
Key inclusion criteria
Patients with potential cervical injuries following an acute injury due to blunt trauma with normal CT scans or plain radiographs.
Patients who underwent subsequent MRI scans after normal CT scan or plain radiographs, either internally at Royal Perth Hospital or externally from other sites with images available on PACS-RIS and full report accessible.
Patients with persistent cervical tenderness, abnormal neurology or remain clinically unevaluable due to various aetiologies such as traumatic brain injury, drug intoxication, sedation, intubation or pre-existing neurological conditions
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with any abnormality on CT scan or plain radiography were excluded from this study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Statistical analysis was performed using the SPSS Statistics 22 program to determine means and standard deviations of patient demographics. Using chi square tests, crosstab analysis was performed between different key variables to generate p values and 95% confidence intervals. A p value of =0.05 was considered to be statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/07/2017
Date of last participant enrolment
Anticipated
Actual
2/12/2017
Date of last data collection
Anticipated
Actual
2/12/2017
Sample size
Target
300
Accrual to date
Final
301
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 14569 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 27589 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 303580 0
Hospital
Name [1] 303580 0
Royal Perth Hospital
Country [1] 303580 0
Australia
Primary sponsor type
Individual
Name
Dr Jean Ai Adeline Yap
Address
Royal Perth Hospital, Victoria Square, Perth, WA 6000
Country
Australia
Secondary sponsor category [1] 303664 0
Individual
Name [1] 303664 0
Dr Swithin Song
Address [1] 303664 0
Royal Perth Hospital, Victoria Square, Perth, WA 6000
Country [1] 303664 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304109 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 304109 0
Royal Perth Hospital, Victoria Square, Perth, WA 6000
Ethics committee country [1] 304109 0
Australia
Date submitted for ethics approval [1] 304109 0
01/07/2017
Approval date [1] 304109 0
27/07/2017
Ethics approval number [1] 304109 0
RGS0000000359

Summary
Brief summary
Following acute blunt cervical injury, there is ongoing debate regarding the reliability of Computed Tomography (CT) and plain radiographs versus the need for Magnetic Resonance Imaging (MRI).

The objectives of this study was to determine the incidence of new findings found on MRI following normal CT or plain radiographs in patients with persistent cervical tenderness, focal neurology or in patients who are clinically unevaluable; and to assess if the management was altered following MRI results.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95838 0
Dr Jean Ai Adeline Yap
Address 95838 0
Royal Perth Hospital, Victoria Square, Perth, WA 6000
Country 95838 0
Australia
Phone 95838 0
+61 892242244
Fax 95838 0
Email 95838 0
[email protected]
Contact person for public queries
Name 95839 0
Jean Ai Adeline Yap
Address 95839 0
Royal Perth Hospital, Victoria Square, Perth, WA 6000
Country 95839 0
Australia
Phone 95839 0
+61892242244
Fax 95839 0
Email 95839 0
[email protected]
Contact person for scientific queries
Name 95840 0
Adeline Yap
Address 95840 0
Royal Perth Hospital, Victoria Square, Perth, WA 6000
Country 95840 0
Australia
Phone 95840 0
+61892242244
Fax 95840 0
Email 95840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the sensitive nature of mechanism of injuries, participant data will not be made available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 378195-(Uploaded-21-08-2019-10-51-55)-Basic results summary.docx
Plain language summaryNo There were 301 patients included in this retrospec... [More Details]

Documents added automatically
No additional documents have been identified.