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

NCT ID: NCT03107767

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2019-06-01

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.

Conditions

Ankle Fractures; Surgery; Syndesmotic Injuries; Posterior Malleolus Fractures

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prospective Cohort

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

Group Type: ACTIVE_COMPARATOR

PRO-malleol algorithm

Intervention Type: PROCEDURE

An evidence based algorithm for ankle fractures

Historical Cohort

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PRO-malleol algorithm

An evidence based algorithm for ankle fractures

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peter Toft Tengberg

Consultant, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hvidovre University Hospital

Hvidovre, , Denmark

Site Status: RECRUITING

Countries

Denmark

Facility Contacts

Peter T Tengberg, MD

Role: primary

ptofttengberg@gmail.com

+4561663676

Peter T Tengberg, MD

Role: backup

peter.toft.tengberg@regionh.dk

+4522971007

Other Identifiers

PRO-Malleol study

Identifier Type: -

Identifier Source: org_study_id