Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT03107767
Status:
UNKNOWN
Last Update Posted:
2017-04-11
First Post:
2017-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Re-operation Rate After Introduction of Evidence Based Algorithm for the Treatment of Ankle Fractures
Sponsor:
Hvidovre University Hospital
Organization:
Study Overview
Official Title:
The PRO-malleol Study
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRO-Malleol
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: