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

Hvidovre University Hospital

Status: Unknown

Conditions: Posterior Malleolus Fractures; Surgery; Syndesmotic Injuries; Ankle Fractures

Treatments: Procedure: PRO-malleol algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT03107767

PRO-Malleol study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Prospective Cohort

Active Comparator group

Description:

The prospective cohort following introduction of the evidence based algorithm for ankle fractures.

Treatment:

Procedure: PRO-malleol algorithm

Historical Cohort

No Intervention group

Description:

Patients treated before introduction of algorithm. Matched to prospective cohort for comparison