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

Surgery Clinical Trial

— PRO-Malleol  

Official title:

The PRO-malleol Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03107767
• Other study ID #: PRO-Malleol study
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2017
• Last updated: April 5, 2017
• Start date: June 1, 2016
• Est. completion date: June 1, 2019

Study information

• Verified date: April 2017
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Ankle Injuries
• Fractures, Bone
• Posterior Malleolus Fractures
• Surgery
• Syndesmotic Injuries

Intervention

Procedure:
• PRO-malleol algorithm
An evidence based algorithm for ankle fractures

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in re-operation rate	Change in re-operation rate following introduction of PRO malleol algorithm	one year
Primary	Rate of surgery for isolated lateral ankle fractures	Rate of surgery for isolated lateral ankle fractures, following introduction of algorithm	one year
Secondary	SF 36	SF 36 before fracture and at 12 months	day 0 and 12 months
Secondary	Ollerud Molander Ankle Score		Before fracture, 6 weeks, 12 weeks and 1 year
Secondary	Forgotten Joint Score	Before fracture, 6 weeks, 12 weeks and 1 year	Before fracture, 6 weeks, 12 weeks and 1 year
Secondary	Rate of complications not requiring surgery	DVT, Nerve damage,	One year