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Completed

NCT Number: NCT03741556

Prognostic Factors Following Ankle Fractures

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.

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Key information

Conditions

Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amager Hvidovre Hospital, Copenhagen, Denmark

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with ankle fracture.

Exclusion criteria

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

Treatment and study plan

Questionaire

Other

a questionaire is sent to each participans

Primary outcomes

  1. Manchester foot and ankle questionnaire (MOXFQ)

    Time frame: 2 years

    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. Self-reported foot and ankle questionnaire (SEFAS)

    Time frame: 2 years

    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.

  3. Olerud Molander Ankle Score (OMAS)

    Time frame: 2 years

    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

  4. Forgotten Joint Score (FJS)

    Time frame: 2 years

    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

Secondary outcomes

  1. EQ5D-3L

    Time frame: 2 years

    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

Sponsors and collaborators

Lead sponsor

Sygehus Lillebaelt

Other

Collaborators

  • Kolding Sygehus

Registry information

Official study title

Recovery Following Ankle Fracture Reported by Patient Report Outcome

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Nov 15, 2018
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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