Study of Re-operation Rate After Introduction of Evidence Based Algorithm for the Treatment of Ankle Fractures

Study Overview
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Brief Summary
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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
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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: 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. 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.

Official Title
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The PRO-malleol Study

Conditions
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Ankle Fractures, Surgery, Syndesmotic Injuries, Posterior Malleolus Fractures

Intervention / Treatment
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* Procedure: PRO-malleol algorithm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prospective Cohort<br>The prospective cohort following introduction of the evidence based algorithm for ankle fractures. | Procedure: PRO-malleol algorithm<br>* An evidence based algorithm for ankle fractures<br>|
| No Intervention: Historical Cohort<br>Patients treated before introduction of algorithm. Matched to prospective cohort for comparison | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in re-operation rate | Change in re-operation rate following introduction of PRO malleol algorithm | one year | 
| Rate of surgery for isolated lateral ankle fractures | Rate of surgery for isolated lateral ankle fractures, following introduction of algorithm | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF 36 | SF 36 before fracture and at 12 months | day 0 and 12 months | 
| Ollerud Molander Ankle Score |  | Before fracture, 6 weeks, 12 weeks and 1 year | 
| Forgotten Joint Score | Before fracture, 6 weeks, 12 weeks and 1 year | Before fracture, 6 weeks, 12 weeks and 1 year | 
| Rate of complications not requiring surgery | DVT, Nerve damage, | One year |