Prognostic Factors Following Ankle Fractures

Recovery Following Ankle Fracture Reported by Patient Report Outcome

Ankel fractures is a common fracture. Most patients experience that the regain normal range of motions and limited pain within the first 6 months following ankel fracture, but not all. The aim of the study is to determine if any prognostic factors is associated with a worse outcome.

Study Overview

• Status: Completed
• Conditions: Ankle Fractures
• Intervention / Treatment: Other: questionaire

Detailed Description

Aim of study:

To identify prognostic factors associated with a worse outcome following ankle fractures.

Method:

All operated or non-operated ankle fractures in a period of one year from three different hospitals will be included. The following data will be recorded:

Civil registration number, age, rupture of the syndesmosis, use of alcohol, smoking, diabetes, characteristics of the ankle fracture (AO classification), type of treatment and complications.

Study participants will at time of diagnosis and 6, 12, 52 and 104 weeks following the injury received a questionaire with Manchester foot and ankle questionnaire (MOXFQ), Self-reported foot and ankle questionnaire (SEFAS), Olerud Molander Ankle Score (OMAS) and Forgotten Joint Score (FJS).

Which of the questionaire that should be used in the study will be determined when the questionaires have been compared in a different study.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2650
    • Amager Hvidovre Hospital
  • Kolding, Denmark, 6000
    • Sygehus Lillebaelt
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All patients with an ankle fracture, treated either with an operation or non-operative in one of three hospitals

Description

Inclusion Criteria:

• All patients with ankle fracture.

Exclusion Criteria:

• age below 18 years
• patients who do not speak or understand danish
• mental disable patients

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manchester foot and ankle questionnaire (MOXFQ)	Manchester foot and ankle questionnaire (MOXFQ) a Patient reported outcome measure. The MOXFQ contains 16 items, each with five response options, comprising three dimensions: walking/standing problems (seven items), foot pain (five items), and issues related to social interaction (four items), including feelings of self consciousness about foot/footwear appearance. Responses are each scored from 0 to 4, with 4 representing the most severe response. Item responses are summed to give a score from 0-100, with higher score representing the worse possible	2 years
Self-reported foot and ankle questionnaire (SEFAS)	The Self-reported foot and ankle questionnaire (SEFAS) comprises twelve items relating to pain, limping, swelling, use of orthotics and walking. Response scales vary from 1 to 5, 1 being the most severe response. Item responses are summed to give a score from 12-60, with higher scores representing the best possible.	2 years
Olerud Molander Ankle Score (OMAS)	The Olerud Molander Ankle Score (OMAS) comprises nine items relating to symptoms, physical function and daily activities. The response scales vary from binary to five-points with clinical scoring that reflects the level of disability for individual items. Item responses are summed to give a score from 0 to 100 with higher scores representing the best possible	2 years
Forgotten Joint Score (FJS)	The forgotten Joint Score (FJS) is a 12-item questionnaire concerning the participiants awareness of their artificial joint during ADL. For each question, the participant can choose between 6 response options: never, almost never, seldom, sometimes, mostly, or not relevant for me. All responses are summed from 0-4 with a total score from 0-100 with higher scores representing the worse possible	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ5D-3L	The EQ5D-3L is a generic PROM and does not specifically address foot and ankle disability. The EQ-5D-3L includes five items with a three-point response scale which are scored to give a single index, with 0 representing the worse possible disability. It also includes a visual analoug scale (VAS) to assess general health, ranging from 0-100, with 0 representing the worse possible health state	2 years

Collaborators and Investigators

• Sponsor: Sygehus Lillebaelt
• Collaborators: Kolding Sygehus

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2018
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: Ver2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share the data.

Drug and device information, study documents

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