Displaced Extra-articular Distal Radius Fractures Clinical Trial
Official title:
Volar Internal Plate Fixation vs. Plaster in Extra- Articular Distal Radial Fractures
BACKGROUND:
Fractures of the distal radius are common and account for an estimated 17% of all fractures
diagnosed. Two-thirds of these fractures are displaced and require reduction. Although distal
radius fractures are considered to be relatively harmless, inadequate treatment may result in
impaired function of the wrist. The consequences of post-traumatic loss of function are
comprehensive, both on an individual and a social level, and have long been underestimated.
Despite the substantial implications, no evidence-based treatment method yet exists. Good
results have been described both in patients treated conservatively and surgically.
Nevertheless, 60% of all fractures redislocate after conservative treatment at which point
surgical reduction and fixation is the treatment of choice. Recently, the use of volar
locking plates has become more popular. This type of osteosynthesis employs a volar approach
to the wrist and provides immediate stable fixation of the reduced fracture. This stability
allows for early mobilisation and may therefore result in an improved regain of function. The
aim of this study is to compare the functional outcome following surgical reduction and
fixation with a volar locking plate with the functional outcome following closed reduction
and plaster immobilisation at one year follow-up in patients with displaced extra-articular
distal radius fractures.
DESIGN:
This single blinded randomised controlled trial will randomise between open reduction and
internal fixation with a volar locking plate (intervention group) and closed reduction
followed by plaster immobilisation (control group). The study population will consist of all
consecutive adult patients who are diagnosed with a displaced extra-articular distal radius
fracture which has been adequately reduced at the Emergency Department. The primary outcome
(functional outcome) will be assessed by means of the Disability Arm Shoulder Hand Score
(DASH). Since the treatment allocated involves a surgical procedure, randomisation status
will not be blinded. However, the researcher assessing the outcome at one year will be
unaware of the treatment allocation. In total, 90 patients will be included in this trial
which will be conducted in the Academic Medical Centre Amsterdam and its partners of the
regional trauma care network.
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