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
|Condition or disease||Intervention/treatment|
|Ankle Fractures||Other: questionaire|
Aim of study:
To identify prognostic factors associated with a worse outcome following ankle fractures.
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 [Patient Registry]|
|Estimated Enrollment :||160 participants|
|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|
- Other: questionaire
a questionaire is sent to each participans
- 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
- 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.
- 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
- 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
- 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
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
|Contact: per gundtoft, MDemail@example.com|
|Amager Hvidovre Hospital||Not yet recruiting|
|Copenhagen, Denmark, 2650|
|Contact: Mads Terndrup|
|Kolding, Denmark, 6000|
|Contact: per h gundtoft 4526195112 firstname.lastname@example.org|
|Principal Investigator: per h gundtoft, md|
|Odense University Hospital||Not yet recruiting|
|Odense, Denmark, 5000|
|Contact: per gundtoft 66113333 email@example.com|