The PRO-malleol Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in re-operation rate
Study Overview
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:
- 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.
- 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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Historical Cohort
Patients treated before introduction of algorithm. Matched to prospective cohort for comparison
Prospective Cohort
The prospective cohort following introduction of the evidence based algorithm for ankle fractures.
Intervention: PRO-malleol algorithm (Procedure)
Outcomes
Primary Outcomes
Change in re-operation rate
Time Frame: one year
Change in re-operation rate following introduction of PRO malleol algorithm
Rate of surgery for isolated lateral ankle fractures
Time Frame: one year
Rate of surgery for isolated lateral ankle fractures, following introduction of algorithm
Secondary Outcomes
- Rate of complications not requiring surgery(One year)
- 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)
- SF 36(day 0 and 12 months)
Investigators
Peter Toft Tengberg
Consultant, PhD
Hvidovre University Hospital