The objective of this study is to investigate, in patients with closed subcapital fractures of the fifth metacarpal, whether functional treatment leads to better or equal results compared to splinting, regarding handfunction, fracture healing,…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical outcome, i.e. handfunction according to DASH-score
Secondary outcome
Fracture healing (including malunion/nonunion)
Range of motion of the fifth MCP joint, pulling strength of the fifth finger
Pain
Patient satisfaction
Time till resumption of daily activities and work
Background summary
Subcapital fractures of the fifth metacarpal are frequently seen in the ER.
They account for 20 percent of all hand fractures. At present, the treatment of
these fractures consists of splinting during three weeks. However, management
of these fractures is still a matter of debate and an alternative treatment
could be functional treatment, e.g. an elastic bandage, taping, a brace or a
pressure bandage during one week.
Functional treatment offers several advantages in contrast to splinting. It
costs less, is easier to apply, is patient-friendly and presumably leads to
earlier recovery of handfunction and thus to earlier resumption of daily
activities and return to work.
Preceding studies are of insufficient quality to make definitive conculsions
(see protocol). Moreover, hand function has never been assessed in a validated
manner. In this study, hand function will be assessed by means of the validated
DASH-score, which has never been done before.
Study objective
The objective of this study is to investigate, in patients with closed
subcapital fractures of the fifth metacarpal, whether functional treatment
leads to better or equal results compared to splinting, regarding handfunction,
fracture healing, patient satisfaction, time till return to work and pain.
Study design
Between 01-01-2010 and 01-06-2010, adult patients (18 years or older with
normal mental competence) who present at the Emergency Department of the Rode
Kruis Hospital in Beverwijk with a subcapital fracture of the fifth metacarpal
will be included in this study. All open fractures, fractures with a rotational
deformity, fractures older than 72 hours, pathological fractures, re-fractures
or fractures angulated by more than 70 degrees, will be excluded from the
study. Before inclusion in the study, an informed consent will be obtained.
An anticipated number of 60 patients will be randomly allocated using block
randomisation either to treatment with a volar plaster cast for a period of
three weeks, or to treatment with an elastic bandage for one week. Follow up
will be as usual, at 1, 3 and 6 weeks, and at 3 months. After 3 weeks and 3
months, an X-ray of the hand in two directions will be made, to evaluate
fracture healing. Patients will be asked to fill in a DASH-questionnaire at
presentation at the ER and at 6 weeks and 3 months follow up in order to
evaluate handfunction. The results of these questionnaires will be compared to
assess recovery of hand function. During the follow up visits, function of the
fifth MCP joint (range of motion, grip strength) will be evaluated.
Any experienced pain will be evaluated by means of a VAS score list.
Intervention
One group will be receiving standard treatment, i.e. a volar plaster cast
during 3 weeks (control group).
The other group will be treated with an elastic bandage during one week
(intervention group).
Study burden and risks
Burden: one extra X-ray of the hand (+/- 0.2 mSv)
Although not anticipated, based on earlier studies, functional treatment may
negatively influence fracture healing as compared to splinting. Also, it is
possible that patients in the intervention group will expreience more pain.
The most important advantage of functional treatment is an anticipated earlier
recovery of hand function and thus earlier resumption of daily activities and
return to work.
Vondellaan 13
1942 LE Beverwijk
Nederland
Vondellaan 13
1942 LE Beverwijk
Nederland
Listed location countries
Age
Inclusion criteria
Patients from the age of 18 (male and female), with normal mental competence
and a closed subcapital fracture of the fifth metacarpal presenting on the ER.
Exclusion criteria
open fractures
fractures with rotational deformity
fractures with an angulation by more than 70 degrees
age under 18 or incapacitated adults
pathological fractures
fractures older than 72 hours
re-fractures
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 |
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CCMO | NL24847.094.09 |