Surgery Clinical Trial
Official title:
The PRO-malleol Study
There is a high incidence of re-operations after surgery for ankle fractures. According to
the Danish Fracture Database (DFDB) the re-operation rate, excluding hardware removal, is
almost 10%.
We are conducting a study on the efficacy of an evidence based algorithm for the treatment
of ankle fractures.
Treatment of ankle fractures is complex and includes assessment of fracture pattern,
severity of soft-tissue involvement and general health- and functional status of the
patients. Historically most fractures, undisplaced as well as displaced, were treated
non-operatively with acceptable results but in recent years there is an increasing trend
towards operative management of unstable fractures. Techniques for operative management of
ankle fractures are varied and assessment of instability is mainly based on classic x-ray
classification systems such as Lauge-Hansen or the AO that are difficult to reproduce[6].
We hypothesize that a standardized and evidence based approach to ankle fracture management
will lead to a decrease in re-operation rate.
The aim of this study is to standardize the management of ankle fractures in our department,
by introducing an algorithm based on best evidence present. We want to investigate:
1. The effect of this algorithm on the re-operation rate of surgically treated ankle
fractures in a two-year prospective observational setup with a minimum of one-year of
follow-up.
2. The need for surgery and functional outcome of patients with isolated lateral malleolus
fractures in which the treatment is dictated by ankle stability assessed on weight
bearing radiographs.
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