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

The PRO-malleol Study

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.

Study Overview

• Status: Unknown
• Conditions: Surgery; Ankle Fractures; Syndesmotic Injuries; Posterior Malleolus Fractures
• Intervention / Treatment: Procedure: PRO-malleol algorithm

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Recruiting
    • Hvidovre University Hospital
    • Contact: Peter T Tengberg, MD; Phone Number: +4561663676; Email: ptofttengberg@gmail.com
    • Contact: Peter T Tengberg, MD; Phone Number: +4522971007; Email: peter.toft.tengberg@regionh.dk
    • Principal Investigator: Peter T Tengberg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prospective Cohort; The prospective cohort following introduction of the evidence based algorithm for ankle fractures.	Procedure: PRO-malleol algorithm; An evidence based algorithm for ankle fractures
No Intervention: Historical Cohort; Patients treated before introduction of algorithm. Matched to prospective cohort for comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in re-operation rate	Change in re-operation rate following introduction of PRO malleol algorithm	one year
Rate of surgery for isolated lateral ankle fractures	Rate of surgery for isolated lateral ankle fractures, following introduction of algorithm	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF 36	SF 36 before fracture and at 12 months	day 0 and 12 months
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	Before fracture, 6 weeks, 12 weeks and 1 year
Rate of complications not requiring surgery	DVT, Nerve damage,	One year

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Ankle Injuries; Ankle Fractures
• Other Study ID Numbers: PRO-Malleol study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be anonymized and openly shared with any who requests it, after study publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No