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

Primary Purpose

Ankle Fractures, Surgery, Syndesmotic Injuries

Status

Unknown status

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

PRO-malleol algorithm

About this trial

This is an interventional treatment trial for Ankle Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hvidovre University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Prospective Cohort

Historical Cohort

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in re-operation rate

Change in re-operation rate following introduction of PRO malleol algorithm

Rate of surgery for isolated lateral ankle fractures

Rate of surgery for isolated lateral ankle fractures, following introduction of algorithm

Secondary Outcome Measures

SF 36

SF 36 before fracture and at 12 months

Ollerud Molander Ankle Score

Forgotten Joint Score

Before fracture, 6 weeks, 12 weeks and 1 year

Rate of complications not requiring surgery

DVT, Nerve damage,

Full Information

NCT ID

NCT03107767

First Posted

April 5, 2017

Last Updated

April 5, 2017

Sponsor

Hvidovre University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03107767

Brief Title

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

Acronym

PRO-Malleol

Official Title

The PRO-malleol Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2016 (Actual)

Primary Completion Date

June 1, 2018 (Anticipated)

Study Completion Date

June 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hvidovre University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle Fractures, Surgery, Syndesmotic Injuries, Posterior Malleolus Fractures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

A prospective cohort, following the introduction of an evidence based algorithm, will be compared to a matched historical cohort from the previous years.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prospective Cohort

Arm Type

Active Comparator

Arm Description

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

Arm Title

Historical Cohort

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

PRO-malleol algorithm

Intervention Description

An evidence based algorithm for ankle fractures

Primary Outcome Measure Information:

Title

Change in re-operation rate

Description

Change in re-operation rate following introduction of PRO malleol algorithm

Time Frame

one year

Title

Rate of surgery for isolated lateral ankle fractures

Description

Rate of surgery for isolated lateral ankle fractures, following introduction of algorithm

Time Frame

one year

Secondary Outcome Measure Information:

Title

SF 36

Description

SF 36 before fracture and at 12 months

Time Frame

day 0 and 12 months

Title

Ollerud Molander Ankle Score

Time Frame

Before fracture, 6 weeks, 12 weeks and 1 year

Title

Forgotten Joint Score

Description

Before fracture, 6 weeks, 12 weeks and 1 year

Time Frame

Before fracture, 6 weeks, 12 weeks and 1 year

Title

Rate of complications not requiring surgery

Description

DVT, Nerve damage,

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Hvidovre University Hospital

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter T Tengberg, MD

Phone

+4561663676

ptofttengberg@gmail.com

First Name & Middle Initial & Last Name & Degree

Peter T Tengberg, MD

Phone

+4522971007

peter.toft.tengberg@regionh.dk

First Name & Middle Initial & Last Name & Degree

Peter T Tengberg, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data will be anonymized and openly shared with any who requests it, after study publication.

Learn more about this trial

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

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