The aim of the current study is to assess the potential time- and cost-savings of fluoroscopically aided reductions of dislocated DRFs in adult patients.
ID
Source
Brief title
Condition
- Bone and joint injuries
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the total time needed for reduction
Secondary outcome
Time in ED
Time of sub-processes of the reduction process
Acceptable reduction as defined by >15° radial inclination and >5 mm radial
height and <20° volar tilt
Total amount of reduction attempts defined as removing the applied splint for a
new reduction
Total amount of hematoma blocks administered
Initial management (conservative or surgical)
Radiation exposure per reduction attempt for the patient
Radiation exposure to the hands of the practitioner as measured by a ring
dosimeter
Radiation exposure to the chest of the practitioner as measured by an
electronic personal dosimeter which is attached to the lead apron at the height
of the manubrium of the sternum
Secondary dislocation on a radiograph performed at one week warranting a change
from conservative to surgical management
Costs as defined by the difference in utilities by, amongst others, time,
splinting materials, amount of attempts and success-rate of reduction
Background summary
Initial management of dislocated distal radius fractures (DRFs) in the
Emergency Department (ED) usually consists of closed reduction and splint
application. When using a mini-C-arm device to fluoroscopically aid the
reduction of DRFs in adult patients, this does not improve reduction quality
when compared to standard reduction techniques. However, research regarding
time- and cost-savings could elucidate potential benefits that could justify
the use of a mini-C-arm device.
Study objective
The aim of the current study is to assess the potential time- and cost-savings
of fluoroscopically aided reductions of dislocated DRFs in adult patients.
Study design
Randomized controlled trial
Intervention
Using a mini-C-arm to fluoroscopically aid the reduction process and perform
post-reduction radiographs
Study burden and risks
A low level risk was estimated following a prospective risk analysis regarding
the use of a mini-C-arm device in the ED performed by, amongst others, a
radiological resident, a surgical resident, a healthcare technology expert and
a medical physicist (Table 1).
Imaging procedures and estimated radiation exposure in both study arms:
The following calculations are based on reported radiation exposure in a study
by Lee et al, radiation dose measurements during a demo session and data from
the hospital PACS system.
Traditional reduction:
Two (AP + lateral) x-ray images pre-reduction without cast by Bucky: 0.2 mGy
Two (AP + lateral) x-ray images post-reduction with cast by Bucky: 0.4 mGy
Total radiation exposure: 0.6 mGy
Mini-C-arm reduction:
Two (AP + lateral x-ray images pre-reduction without cast by Bucky: 0.2 mGy
Three images (single shot, not continuous) without cast by mini-C-arm: 0.18 mGy
Two images (single shot, not continuous) with cast by mini-C-arm: 0.24 mGy
Total radiation exposure: 0.62 mGy
Estimated radiation exposure healthcare worker
As stated in the Besluit basisveiligheidsnormen stralingsbescherming the
maximum allowed radiation exposure in the Netherlands for non-exposed
healthcare workers) is 50 milisievert (mSv) or 50.000 microsievert (µSv) per
year for the extremities and 1 mSv or 1000 microsievert per year for the body.
Based on our own measurements using dosimeters, the estimated radiation
exposure to the hands using the mini-C-arm is approximately 0.07-0.12 mSv or
7-12 microsievert (µSv) per image. During these tests, we did not measure any
scatter radiation on any dosimeter that was not directly in the beam of the
mini-C-arm, which is also confirmed by several studies. While performing a
reduction, the practitioner will have to maintain the position of the reduced
distal radius until a cast has been applied. This means that, while performing
imaging during reduction, the hands of the practitioner will be near the direct
beam of the mini-C-arm. To over-estimate the radiation exposure of the
practitioner it is assumed that the hands of the practitioner are indeed
positioned withing the primary x-ray beam, resulting in an exposure of not more
than 0.18 mGy per procedure. With a total of 46 procedures, the total exposure
is estimated at 8.3 mGy. Since it is highly likely that these procedures are
performed by multiple individuals (approximately 20 practitioners that perform
these reductions work in our ED), the estimated individual radiation exposure
assuming a maximum of three reductions per person during this study is 0,54
mSv. Compared to the maximum allowed exposure of 50 mSv/year, this is a minor
and acceptable radiation exposure that is well below the limits for healthcare
professionals as set by the Dutch government. In addition no significant
radiation exposure to the body is expected. However, practitioners will wear a
lead apron during the procedure as obligated by hospital regulations
Estimated radiation exposure for the patient
For the patient no maximum allowed dose limits are set, but it is important to
work according to the As Low As Reasonably Achievable (ALARA) principle. Risks
were assessed following the guideline of the Netherlands Commission for
Radiation Dosimetry, which suggests classification into three risk categories.
A medical physicist was involved in this risk assessment. Previous studies
reported that radiation exposure in the mini-C-arm group is be lower than
radiation exposure in the standard group, however, this has not been studied
specifically in adult patients with a DRF requiring reduction. Based on the
above calculations the radiation exposure in both study arms are practically
comparable, assuming one reduction attempt is needed. Any differences found are
expected to be in a negligible range of several microsieverts. Therefore, the
risk classification of this study following from the effective dose is category
I, implicating a statistical probability of less than 5 in a million to develop
radiation induced cancer. In this category, only a minor level of benefit is
sufficient to approve research, including investigations that aim to increase
knowledge, which is the purpose of this study.
Jan Tooropstraat 164
Amsterdam 1061 AE
NL
Jan Tooropstraat 164
Amsterdam 1061 AE
NL
Listed location countries
Age
Inclusion criteria
Patients >=18 years
Presenting to the ED with a dislocated distal radius fracture requiring closed reduction
Exclusion criteria
Ipsilateral upper extremity fractures
Open fracture
Pregnancy
Neurovascular compromise requiring immediate surgical intervention
Design
Recruitment
Medical products/devices used
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 | NL66132.100.18 |