The aim of the study is to prove that the functional outcome of distal radial fractures is better after four weeks of plaster cast immobilization than after six weeks of plaster cast immobilization in adult patients.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functional outcome in adult patients with a distal radius fracture as assessed
using the
a. Quick Disability of Arm, Shoulder and Hand (DASH) score and
b. Patient Related Wrist Evaluation
Secondary outcome
Secondary Objective(s):
1. Range of motion
2. Pain (assessed by the VAS scale)
3. Time to union
4. Complications: complex regional pain syndrome and mal/ nonunion
Background summary
The incidence of distal radial fractures is 400/100.000 in the Netherlands.
Therefore, these fractures represent a large amount of the daily workload for
practicing orthopedic and trauma surgeons. Most patients with distal radius
fractures can be treated non-operatively in a plaster of Paris, with excellent
functional results.
In case of conservative treatment of reduced distal radius fractures a little
is known about the duration of plaster cast immobilization. Usually a period of
six weeks is chosen. Christensen showed in a clinical controlled trial with 33
patient that immobilization of nearly of non-dislocated distal radius fractures
could be reduced from 5 till 3 weeks. Vang Hansen confirmed these findings
later with a prospective comparative with 100 patients. Jensen showed in a
randomized trial with 62 patients that even one week of immobilization was
sufficient.
In the above mentioned studies it has already been shown that a reduction in
period of immobilization could be possible. However the above mentioned studies
have their limitations in follow up and their modest group of patients.
moreover these studies do not represent the reduced distal radial fractures.
Study objective
The aim of the study is to prove that the functional outcome of distal radial
fractures is better after four weeks of plaster cast immobilization than after
six weeks of plaster cast immobilization in adult patients.
Study design
This study will be conducted as a prospective randomized controlled clinical
trial in which four weeks of plaster cast immobilization is compared to six
weeks of plaster cast immobilization. Patients with distal radius fractures
will be initially managed on the emergency department. Using the criteria for
misalignment (dorsal angulation >15°, volar tilt >20°, radial inclination >15°
and, ulnar variance >5mm) the patients will be included if closed reduction is
necessary.
Patients will be asked informed consent after fulfilling the above-mentioned
inclusion and exclusion criteria. Two (non-treating) trauma surgeons as
external referees will also determine the degree of misalignment and the AO
classification blinded from the scoring by the treating physician. Thereafter
patients will be randomized into a group in which the plaster cast
immobilization is continued for four weeks or six weeks.
Intervention
One group will have four weeks of plaster immbilization and the other group
will have six weeks of plaster immobilization
Study burden and risks
Literature indicates that both treatment options are accepted for distal radial
fractures. No clear advantage for one treatment option is found at present in
the literature, although there is no level I evidence present. Both treatment
options have their known complications: stiffness of the joint and pain due to
malunion.
The expectation of this study is that four weeks of plaster immobilization is
beneficial for the patient with a distal radius fracture. This risk of specific
complications is low and generally similar in both treatment options. Moreover,
the burden of the study is not much higher compared to standard treatment.
Spaarnepoort 1
2134 TM
NL
Spaarnepoort 1
2134 TM
NL
Listed location countries
Age
Inclusion criteria
1. Age > 18 years
2. Unilateral fracture of distal radius with misalignment (dorsal angulation >15°, volar tilt >20°, radial inclination >15° and, ulnar variance >5mm)
3. Independent for activities of daily living
Exclusion criteria
1. Fracture of contralateral arm
2. Other fractures at the ipsilateral arm (excluded carpal fractures)
3. Pre-existent abnormalities fractured distal radius
4. Open fractures
5. Inadequate reduction of distal radius at 1 week follow-up at the outpatient department
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 | NL38463.094.11 |