Radiological issues in spinal immobilization
| ISRCTN | ISRCTN68626238 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68626238 |
| Protocol serial number | METC 13-4-113 |
| Sponsor | Maastricht University Medical Center |
| Funder | Maastricht University Medical Center (Netherlands) |
- Submission date
- 16/07/2015
- Registration date
- 18/08/2015
- Last edited
- 04/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Bogaartsborg 3
Maastricht
6228AK
Netherlands
Study information
| Primary study design | Observational |
|---|---|
| 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 |
| Secondary study design | |
| Study type | Participant information sheet |
| Scientific title | Radiation exposure and objective and subjective image quality in spinal immobilization: a comparison of patient data and phantom data |
| Study objectives | Devices for spinal immobilization decrease image quality and increase radiation exposure |
| Ethics approval(s) | METC MUMC (Medical Ethics Committee of the Maastricht University Medical Center), 19/12/2013, ref: METC 13-4-113 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
Overall assessment of the question which device for spinal immobilization performs best from a radiological point of view, with recommendations for clinical use. |
| Completion date | 01/06/2015 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 241 |
| Key inclusion criteria | Patients who underwent CT of the head in 2011 while on a device for spinal immobilization, aged 18 or older |
| Key exclusion criteria | Patients are excluded when the type of device(s) used are unknown |
| Date of first enrolment | 01/01/2014 |
| Date of final enrolment | 01/03/2014 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
6202AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
