Ankle FracturesNCT03741556
Prognostic Factors Following Ankle Fractures
An observational study of Ankle Fractures, run by Sygehus Lillebaelt at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- questionaire
- How many people
- 160 participants
- Where
- 3 sitesDenmark
- Study dates
- 7 Nov 2018to 1 Oct 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients with an ankle fracture, treated either with an operation or non-operative in one of three hospitals
Who may be able to join
- All patients with ankle fracture.
Who cannot join
- age below 18 years
- patients who do not speak or understand danish
- mental disable patients
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Amager Hvidovre Hospital
Copenhagen, 2650
Sygehus Lillebaelt
Kolding, 6000
Odense University Hospital
Odense, 5000
About this study
Official title: 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.
Read the 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.
- Conditions
- Ankle Fractures
- Being tested
- questionaire
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionaireOther
a questionaire is sent to each participans
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 2 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start7 Nov 2018
- Primary completion1 Jul 2020
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sygehus Lillebaelt
- Sponsor type
- University, hospital or other
- Collaborators
- Kolding Sygehus
- Responsible party
- Principal investigator, per hviid gundtoft, Sygehus Lillebaelt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741556
- Sponsor's protocol ID
- Ver2
- Status last verified
- Aug 2023
- First submitted
- 6 Nov 2018
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share the data.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Following Ankle Fracture Reported by Patient Report Outcome
- ClinicalTrials.gov ID
- NCT03741556
- Acronym / sponsor ID
- Ver2
- Conditions
- Ankle Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Sygehus LillebaeltUniversity, hospital or other
- Collaborators
- Kolding Sygehus
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with an ankle fracture, treated either with an operation or non-operative in one of three hospitals
Key inclusion criteria (1 listed)
- All patients with ankle fracture.
Key exclusion criteria (3 listed)
- age below 18 years
- patients who do not speak or understand danish
- mental disable patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionairea questionaire is sent to each participans | Other | – |
Primary outcome
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
1 secondary outcome
EQ5D-3L
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No. We do not plan to share the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Fractures, run by Sygehus Lillebaelt at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manchester foot and ankle questionnaire (MOXFQ) (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.