To perform a pilot study to quantify difference in treatment plans based on CR, as compared to treatment planning based on CT in all patients with clinical suspicion of fractures of the wrist and carpus. Information from this pilot study will be…
ID
Source
Brief title
Condition
- Bone and joint injuries
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the proportion of patients with prospectively
documented treatment changes after CT.
Secondary outcome
One secondary endpoint is the proportion of patients with difference in
fracture pattern detection before and after CT.
Second secondary endpoint is mean patient outcome according to the patient
rated wrist/hand evaluation (PRWHE) score.
Background summary
Fractures of the wrist and carpus are very common, especially fractures of the
distal radius scaphoid. If treated inadequately, these fractures cause longterm
pain and disability. Conventional radiography of the wrist and carpus (CR) is
the standard imaging test in diagnosing fractures. However, CR underestimates
the presence of fractures and severity of fracture patterns. Computed
tomography of the hand and wrist (CT) improves fracture detection and treatment
planning in this type of injury. CT is not accepted as a standard imaging
modality in all patients with suspicion on fractures, as this is a
time-consuming and expensive investigation with relatively high ionizing
radiation dose as compared to CR.
We implemented a fast set-up and low-radiation dose volume CT protocol in our
clinic. We hypothesize that standard use of this CT in all patients with
suspicion of fractures of the wrist and carpus increases fracture detection and
changes treatment plans in a substantial number of patients, ultimately
improving longterm patient outcome.
Study objective
To perform a pilot study to quantify difference in treatment plans based on CR,
as compared to treatment planning based on CT in all patients with clinical
suspicion of fractures of the wrist and carpus. Information from this pilot
study will be used to ultimately perform a randomised controlled trial to to
investigate the effect of standard CT on patient outcome.
Study design
Prospective, observational pilot study
Study burden and risks
All patients will undergo CT scanning of the hand and carpus, although for some
patients this is not according to clinical guidelines. This CT is associated
with a radiation dose of approximately 0.05 mSv, which encompasses a trivial
risk as compared to the natural background radiation in the Netherlands (2 mSv).
All patients have to complete an online questionnaire (PRWHE score) with 17
questions during their vistit at the department of radiology and after 6 weeks,
6 months, and 1 year.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Patients (18 years and older) who are referred to our hospital for conventional radiography of the wrist and carpus and a recent trauma mechanism (within 3 days before presentation) and clinical suspicion of fractures of the wrist and carpus.
Exclusion criteria
-Patients who were not evaluated by a clinician before imaging was performed
-Open fractures
-No informed consent or no prospective data collection could be obtained
-Patients who cannot be positioned in upright position, immobilized on a spineboard or transferred to the intensive care unit and cannot undergo upright CT
-(Suspected) pregnancy
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 | NL43482.091.13 |