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

NCT03107767 | Unknown

• 1 other identifier: PRO-Malleol study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Fractures; Surgery; Syndesmotic Injuries; Posterior Malleolus Fractures

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• SF 36

  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

• Rate of complications not requiring surgery

  One year

Study Arms (2)

Prospective Cohort

ACTIVE COMPARATOR

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

Procedure: PRO-malleol algorithm

Historical Cohort

NO INTERVENTION

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

Interventions

PRO-malleol algorithm PROCEDURE

An evidence based algorithm for ankle fractures

Prospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients treated for ankle fractures at our institution during the study period are asked to participate in the study.

You may not qualify if:

• Not speaking danish Not followed up at our institution Not mentally capable of filling out questionnaire

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Ankle Fractures; Ankle Injuries

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, PhD

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

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 11, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: April 11, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)