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

Not Applicable

• Conditions: Surgery; Syndesmotic Injuries; Ankle Fractures; Posterior Malleolus Fractures
• Interventions: Procedure: PRO-malleol algorithm

• Registration Number: NCT03107767
• Lead Sponsor: Hvidovre University Hospital

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.

Study Timeline

• Study Start: 2016-06-01
• Status Verified: 2017-04
• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-05
• Last Update Submitted: 2017-04-05
• Study First Posted: 2017-04-11
• Last Update Posted: 2017-04-11
• Primary Completion: 2018-06-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Prospective Cohort	PRO-malleol algorithm	The prospective cohort following introduction of the evidence based algorithm for ankle fractures.

Primary Outcome Measures

Name	Time	Method
Change in re-operation rate	one year	Change in re-operation rate following introduction of PRO malleol algorithm
Rate of surgery for isolated lateral ankle fractures	one year	Rate of surgery for isolated lateral ankle fractures, following introduction of algorithm

Secondary Outcome Measures

Name	Time	Method
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	One year	DVT, Nerve damage,
SF 36	day 0 and 12 months	SF 36 before fracture and at 12 months

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark