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Prognostic Factors Following Ankle Fractures

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ClinicalTrials.gov Identifier: NCT03741556
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
Kolding Sygehus
Information provided by (Responsible Party):
per hviid gundtoft, Sygehus Lillebaelt

Brief Summary:
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.

Condition or disease Intervention/treatment
Ankle Fractures 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 160 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Recovery Following Ankle Fracture Reported by Patient Report Outcome
Actual Study Start Date : November 7, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: questionaire
    a questionaire is sent to each participans


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

  • All patients with ankle fracture.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741556


Contacts
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Contact: per gundtoft, MD +4526195112 per.hviid.gundtoft@rsyd.dk

Locations
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Denmark
Amager Hvidovre Hospital Not yet recruiting
Copenhagen, Denmark, 2650
Contact: Mads Terndrup         
Sygehus Lillebaelt Recruiting
Kolding, Denmark, 6000
Contact: per h gundtoft    4526195112    per.hviid.gundtoft@rsyd.dk   
Principal Investigator: per h gundtoft, md         
Odense University Hospital Not yet recruiting
Odense, Denmark, 5000
Contact: per gundtoft    66113333    per.hviid.gundtoft@rsyd.dk   
Sponsors and Collaborators
Sygehus Lillebaelt
Kolding Sygehus

Additional Information:

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Responsible Party: per hviid gundtoft, Principal Investigator, Senior House Officer, PhD, Sygehus Lillebaelt
ClinicalTrials.gov Identifier: NCT03741556     History of Changes
Other Study ID Numbers: Ver2
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fractures, Bone
Ankle Fractures
Wounds and Injuries