Primary objective: Minimizing and optimizing radiation dose while maintaining sufficient image quality in patients with THA. Secondary objective: Reducing metal artefacts and thus in addition further improving the overall image quality using O-MAR…
ID
Source
Brief title
Condition
- Other condition
- Bone and joint therapeutic procedures
Synonym
Health condition
Totale heuparthroplastiek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The main study parameters are a current
standard care CT scan and an additional low-dose CT scan with 20%, 40%, 60% or
80% lowered radiation dose. The main endpoints are the objective and subjective
image quality at different radiation dose levels for iterative reconstruction
and model-based iterative reconstruction.
Secondary outcome
Secondary study parameters are metal artefacts. The secondary endpoints are
objective and subjective image quality in conventional non-O-MAR images and
O-MAR images.
Background summary
Rationale: In conventional computed tomography (CT), radiation dose and metal
artefacts are two of the main obstacles limiting its wide use in
musculoskeletal and orthopaedic imaging. Large metal implants in patients with
total hip arthroplasty, cause severe metal artefacts, which strongly
deteriorates image quality and significantly reduces the performance of CT in
the detection of all sorts of prosthesis-related pathology, such as
pseudo-tumours, capsular reactions and other soft tissue and bone pathologies.
The orthopaedic metal artefact reduction algorithm O-MAR is an iterative metal
artefact reduction algorithm specially developed for CT-imaging of large metal
orthopaedic implants. On the other hand, the use of model-based iterative
reconstruction (IMR) techniques enables a significant reduction of radiation
dose in various CT protocols while simultaneously improving overall image
quality. The combined use of O-MAR and IMR in low-dose CT imaging will be
optimized in a challenging population i.e. patients with large metal total hip
arthroplasty (THA) by reducing radiation dose in four different patient groups
with 20%, 40%, 60% or 80%.
Study objective
Primary objective: Minimizing and optimizing radiation dose while maintaining
sufficient image quality in patients with THA.
Secondary objective: Reducing metal artefacts and thus in addition further
improving the overall image quality using O-MAR.
Study design
Study design: Prospective diagnostic mono-centre study. Patients are randomly
divided into four different groups and receive a standard care CT scan at 100%
radiation dose and an additional low dose CT scan with 20%, 40%, 60% or 80%
reduced radiation dose for respectively group 1, 2, 3 and 4.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: The patient does not have benefit from
participating in this study and will receive routine care. For research
purposes an additional low-dose CT-scan is obtained for each patient. The
additional low-dose CT-scan will be analysed after the study has been
completed. This study will contribute to a lower radiation dose in future
patients without compromising on diagnostic accuracy. In future, radiation dose
will likely be reduced in other CT protocols also since we investigate dose
reduction capabilities in one of the most challenging populations.
Veenpluis 4-6
Best 5684PC
NL
Veenpluis 4-6
Best 5684PC
NL
Listed location countries
Age
Inclusion criteria
Patients with a unilateral or bilateral THA replacement.
Exclusion criteria
- No written informed consent
- Patient not meeting the inclusion criteria
- Previous participation in the study
- Pregnant women
- Concomitant participation in a study in which the patient is exposed to X-rays
- Patients younger than 40 years old
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58001.075.16 |