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Prognostic Factors Following Ankle Fractures

Recovery Following Ankle Fracture Reported by Patient Report Outcome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03741556
Enrollment
160
Registered
2018-11-15
Start date
2018-11-07
Completion date
2022-10-01
Last updated
2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fractures

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.

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.

Interventions

OTHERquestionaire

a questionaire is sent to each participans

Sponsors

Kolding Sygehus
CollaboratorOTHER
Sygehus Lillebaelt
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* All patients with ankle fracture.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Manchester foot and ankle questionnaire (MOXFQ)2 yearsManchester 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)2 yearsThe 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)2 yearsThe 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)2 yearsThe 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

MeasureTime frameDescription
EQ5D-3L2 yearsThe 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026