Clinical trial NCT03107767: Study of Re-operation Rate After Introduction of Evidence Based Algorithm for the Treatment of Ankle Fractures
Official title: The PRO-malleol Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Fractures
Surgery
Syndesmotic Injuries
Posterior Malleolus Fractures
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A prospective cohort, following the introduction of an evidence based algorithm, will be compared to a matched historical cohort from the previous years.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All patients treated for ankle fractures at our institution during the study period are asked to participate in the study.

Exclusion Criteria:

* Not speaking danish Not followed up at our institution Not mentally capable of filling out questionnaire

Primary outcomes:
measure: Change in re-operation rate
timeFrame: one year
measure: Rate of surgery for isolated lateral ankle fractures
timeFrame: one year
Secondary outcomes:
measure: SF 36
timeFrame: day 0 and 12 months
measure: Ollerud Molander Ankle Score
timeFrame: Before fracture, 6 weeks, 12 weeks and 1 year
measure: Forgotten Joint Score
timeFrame: Before fracture, 6 weeks, 12 weeks and 1 year
measure: Rate of complications not requiring surgery
timeFrame: One year
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
References: