Condition category
Musculoskeletal Diseases
Date applied
16/07/2015
Date assigned
18/08/2015
Last edited
04/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients who have been in an accident and are suspected of spinal injury are routinely treated with devices for spinal immobilization in order to stabilise the spinal column after injury and therefore prevent injury to the spinal cord. These devices are usually left in place while the patient is in the Emergency Room for assessment, including taking x-rays or making CT scans. However, the presence of these devices may hamper judgement of these images since they can produce artefacts (e.g. lines). Also, the presence of the devices may increase the amount of radiation the patient is exposed to. CT scanners and x-ray machines automatically adjust the radiation dose for imaging to get consistent image quality, and increase the dose when there is more matter (be it patient of device) to beam through. With this study we judge patient CT scans to assess image quality, and we measure radiation exposure using a phantom. We want to know which device therefore produces the best image quality and the least radiation exposure

Who can participate?
Adults (aged at least 18) than had a CT scan of their head while on a device for spinal immobilization in 2011.

What does the study involve?
Patients CT scans are assessed retrospectively for the presence and extent of artifacts caused by the spinal immobilization device used. Phantom CT scans and x-rays are assessed prospectively for radiation exposure in relation to the spinal immobilization device being used.

What are the possible benefits and risks of participating?
There are no benefits or risks to participants.

Where is the study run from?
Maastricht University Medical Center (Netherlands)

When is the study starting and how long is it expected to run for?
August 2013 to December 2014

Who is funding the study?
Maastricht University Medical Center (Netherlands)

Who is the main contact?
Miss Baukje Hemmes

Trial website

Contact information

Type

Scientific

Primary contact

Miss Baukje Hemmes

ORCID ID

Contact details

Bogaartsborg 3
Maastricht
6228AK
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

METC 13-4-113

Study information

Scientific title

Radiation exposure and objective and subjective image quality in spinal immobilization: a comparison of patient data and phantom data

Acronym

Study hypothesis

Devices for spinal immobilization decrease image quality and increase radiation exposure

Ethics approval

METC MUMC (Medical Ethics Committee of the Maastricht University Medical Center), 19/12/2013, ref: METC 13-4-113

Study design

1. Retrospective evaluation of CT scans of patients
2. Prospective evaluation of CT scans and x-rays of a phantom
3. Single center study

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Radiation exposure and radiological image quality

Intervention

1. Patients CT scans are assessed retrospectively for the presence and extent of artifacts in relation to spinal immobilization device used.
2. Phantom CT scans and x-rays are assessed prospectively for radiation exposure in relation to spinal immobilization device used.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Artifacts are scored independently by two trained judges, based on presence and impact of any disturbance of the image, which can be related back to the spinal immobilization device
2. Radiation exposure is measured using an ionisation chamber and electrometer
3. Noise is measured in SD of the CT values (in Hounsfield Units) of the pixels within 16 circular regions of interest covering 51% of the phantom using ImageJ

Secondary outcome measures

Overall assessment of the question which device for spinal immobilization performs best from a radiological point of view, with recommendations for clinical use.

Overall trial start date

01/10/2013

Overall trial end date

01/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who underwent CT of the head in 2011 while on a device for spinal immobilization, aged 18 or older

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

N/A

Participant exclusion criteria

Patients are excluded when the type of device(s) used are unknown

Recruitment start date

01/01/2014

Recruitment end date

01/03/2014

Locations

Countries of recruitment

Netherlands Antilles

Trial participating centre

Maastricht University Medical Center
Maastricht
6202AZ
Netherlands

Sponsor information

Organisation

Maastricht University Medical Center

Sponsor details

P. Debyelaan 25
Maastricht
6229HX
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Maastricht University Medical Center (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results of the study will be offered for publication in peer reviewed international journals and for presentation at a national congress (Traumadagen [Dutch national trauma days]). We intend to offer the manuscript for publication as soon as ISRCTN registration is completed. We intend to give a presentation at the Traumadagen 2016.

Intention to publish date

01/09/2015

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes