We want to find out whether the new protocol (with a fast MRI) is more cost-effective than the current protocol (concisting of 10 days cast). Primary Objective: To find out whether the new MRI protocol is more cost-effective than the old protocol.…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Costs of treatment, including days not attending work, days of plaster
treatment, times of outpatient clinic visits, number of x-rays, times of
consulting the casting-technician, costs of MRI.
Secondary outcome
Hand functioning after 6 weeks, measured by two questionnaires, the Patient
Rated Wrist and Hand Evaluation and the QuickDash.
Both questionnaires are available in Dutch and have been validated. Time for
completion:10 minutes.
Background summary
At the UMCG, 300 patients per year attend the CSO with a suspected fracture of
the scaphoid bone (the scaphoid is a carpal bone). However, the specificity and
sensitivity of physical examination is low. Thereby, sometimes (15-20%) the
fracture is not seen on the initial x-ray (thesis Beeres, 2008). Therefore,
when there is suspicion of a scaphoid fracture, patients are treated with a
cast and are seen at the outpatient clinic after 10 days again. Patients are
treated with a cast even when there is a minimum suspicion, since leaving a
scaphoid fracture untreated can have serious adverse consequences (necrosis and
pseudartrosis).
If patients are still in pain after ten days, a photograph is repeated.
Sometimes a fracture is seen then, the sensitivity of the second X-ray is
however low. If patients have no pain, they are discharged from follow-up, and
are thought to have no fracture. This appears to be the case in approximately
85% of patients.
So, the vast majority (85%) of patients is treated unnecessary with a cast for
10 days.
MRI has a negative predictive value of 99% concerning the presence of a
scaphoid fracture (Yin, 2010). So, if it is possible to do an MRI of the hand
within 0-2 days, a negative MRI can justify to remove the cast immediately.
Patients won*t have to be in a cast for 10 days and might have an earlier
return to work.
We want to find out whether the new protocol (with a fast MRI) is more
cost-effective than the old protocol (with 10 days cast).
In the past, some studies were carried out concerning this cost-effectiveness;
these studies did not all however look at the earlier return to work. The
results of studies from abroad are not comparable to the Dutch situation
however, since different regulations do apply concerning social security and
medical costs. In the Netherlands, there are no earlier studies conducted
comparing the costs, return to work and functioning of the hand in this field.
Study objective
We want to find out whether the new protocol (with a fast MRI) is more
cost-effective than the current protocol (concisting of 10 days cast).
Primary Objective: To find out whether the new MRI protocol is more
cost-effective than the old protocol.
Secondary Objective(s): To asses the patient's functioning of the hand after 6
weeks, and compare between 2 days cast (MRI) and 10 days cast (current
protocol).
Study design
We will conduct a prospective randomized controlled trial.
Patients attending the ER or radiology department with a suspected scaphoid
fracture (with a negative X-ray) will be randomized. One group will be treated
by current protocol (10 days cast, second X-ray), the other group will get a
fast MRI, if the MRI shows no fracture the cast will be removed immediately.
Patients in the MRI group will be seen for revision after a week, to be sure
not to oversee significant other possible injury (muscle contusions etc.)
Randomisation will take place according to week number: patients attending the
CSO in even weeks will get an MRI, patient presenting at uneven weeks will be
treated by the current protocol.
Study burden and risks
There are no risks, since MRI uses no radiation. No contrast media is used.
Time: 20 minutes.
The benefit for the patient is multiple:
No fracture seen on the MRI (85%): no more cast is needed for 8-10 days.
If a fracture is seen (15%): proper treatment can be started right away.
Time for completion of the questionnaires:10 minutes.
The costs for the MRI will be paid by the department of Radiology, patients
will not receive an invoice.
Hanzeplein 1 EB 44
Groningen 9700 RB
NL
Hanzeplein 1 EB 44
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
patients with a suspected fracture of the scaphoid, with a negative x-ray, age 18-60 years.
Time between trauma and visit to the hospital smaller than one week.
Exclusion criteria
Previous scaphoid fracture at the same side.
Poly-trauma patients.
Contra-indications regarding MRI.
Joint diseases like reumatoid artritis.
Insufficient command of the Dutch language.
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 | NL38979.042.12 |