Skip to content

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

The PRO-malleol Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03107767
Acronym
PRO-Malleol
Enrollment
200
Registered
2017-04-11
Start date
2016-06-01
Completion date
2019-06-01
Last updated
2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fractures, Posterior Malleolus Fractures, Surgery, Syndesmotic Injuries

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.

Interventions

PROCEDUREPRO-malleol algorithm

An evidence based algorithm for ankle fractures

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in re-operation rateone yearChange in re-operation rate following introduction of PRO malleol algorithm
Rate of surgery for isolated lateral ankle fracturesone yearRate of surgery for isolated lateral ankle fractures, following introduction of algorithm

Secondary

MeasureTime frameDescription
SF 36day 0 and 12 monthsSF 36 before fracture and at 12 months
Ollerud Molander Ankle ScoreBefore fracture, 6 weeks, 12 weeks and 1 year
Forgotten Joint ScoreBefore fracture, 6 weeks, 12 weeks and 1 yearBefore fracture, 6 weeks, 12 weeks and 1 year
Rate of complications not requiring surgeryOne yearDVT, Nerve damage,

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026