Evaluation of the accuracy of Low Dose CT for detecting dislocation in patients with acetabular fractures
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The distance of fracture displacement measured by Low Dose CT compared to the
distance measured on routinely made CT
Secondary outcome
Radiation exposure parameters as measured from the scanners console:
Volume computed tomography dose index (CTDIvol) and Dose Length product (DLP)
in mGy cm, standard deviation, and scanning length for each scan.
In addition on patient height and weight will be collected.
- Image noise (SD) in an region of interest (ROI) in air
- Beam hardening artifacts
Background summary
The current protocol for patients with internal fixation of acetabular
fractures is to mobilize non weight bearing up to 12 weeks. We know from
unpublished data that the mean time till full weight bearing is 9 weeks (range
0-13 weeks) in our medical center. No further dislocation was observed in these
patients. So this data suggest that time until full weight bearing can be
reduced. Whenever a patient starts to mobilize immediately on a weight bearing
regime, there is a chance of further dislocation of the fracture. So
radiographic control is needed for observing changes in fracture alignment.
There is no data available on radiographic control for immediate weight bearing
after operatively treated acetabular fractures. So before starting a study on
immediate full weight bearing, we need to find out which radiographic control
is capable of detecting changes in fracture alignment after immediate full
weight bearing.
Study objective
Evaluation of the accuracy of Low Dose CT for detecting dislocation in patients
with acetabular fractures
Study design
In this study two patients will be tested:
1. Patient with ORIF for displaced acetabular fracture
2. Patient who is treated conservatively
The patients will be included on the surgical ward. The patient will receive,
preoperatively, an information letter. After 24 hours the patient will be
visited again. He will be asked if he has any question regarding the study.
Whenever the patient feels well informed about the study and willing to
participate, he will be asked to sign the informed consent.
Routinely patients undergo CT for the diagnosis of acetabular fractures. When a
patients is treated operatively they also undergo CT postoperatively.
By participating in our study patients agree to undergo extra Low Dose CT
Fracture dislocation from previously made CT and Low Dose CT will be compared.
By doing so we want to determine of Low Dose CT is capable of detecting
fracture dislocation precisely.
Study burden and risks
Patients will be exposed to extra radiation of approxitmely 1 mSV.
The International Commission of Radiological Protection considers the radiation
exposure of studies with an effective dose of less than 1 mSv as minor category
(category IIa.)8 . A study with such a low radiation exposure is expected to
have social benefit and that the study is being done to gain knowledge which
will lead to potential health improvements.
In addition, there is a time investment for the overall duration of the study
of about an half hour.
Wolfskuilseweg 18F
Nijmegen 6542JK
NL
Wolfskuilseweg 18F
Nijmegen 6542JK
NL
Listed location countries
Age
Inclusion criteria
- Age 50 years of older on the day the informed consent will be signed
- Male gender
- Mentally competent
- Is capable to speak, read and understand Dutch
- Has given oral and written informed consent
- One operative and one conservative treated patient with an acetabular fracture
Exclusion criteria
- Female gender
- BMI >30
- BMI <18
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 | NL53194.091.15 |