Bracing After Ankle Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital
About this trial
Ankle fractures are common, debilitating and usually treated with immobilisation using a foot-ankle brace (walker). Emerging evidence suggests that a less restrictive brace may reduce recovery time without increasing the risk of complications, and patients tend to prefer ankle stirrups. However, evidence supporting their non-inferiority remains limited and inconclusive. Thus, the aim is assess if an ankle stirrup is non-inferior to a standard walker in reducing pain and function measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after ankle fracture. The hypothesis is that ankel stirrups align better with patients preferenes for less immobilising braces and offer sufficient stability while the fracture heals. Secondarily it may lead to faster recovery of function, return to work and reduced cost. The sample size of a maximum of 1400 patients allow us to assess non-inferiority in age and sex specific subgroups and treatment (surgical or non-sugical). Non-inferiority will be assessed in a pragmatic, multicenter, randomised controlled trial involving Scandinavian orthopedic departments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Surgically or non-surgically treated ankle fracture
Disqualifiers
Pathological fractures
Inadequacy to read or speak danish
Open fractures
Prolonged need for immobilisation (e.g. non-union or insufficient wound healing)
Trial design
Design model
Parallel
Treatments tested in this trial
ankel stirrup
Other interventionAnkel stirrups are a patient preferred ankel brace that allow active ankle dorsal and plantar flexion during weightbearing while maintaining lateral stability.
Foot-ankel brace (walker)
Other interventionWalkers immobilise and stabilise the ankle during weightbearing.
Treatment groups
1,400 Participants
are divided into 2 treatment groupsGroup A: foot ankel brace (walker)Active comparator 1 intervention
Group B: Ankel stirrupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Index score (0-100) of the Manchester-Oxford Foot Questionnaire (MOXFQ)
The index score of the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after randomisation is chosen as the primary outcome. Patients prefer MOXFQ, and it is a valid and reliable self-administered 16-item patient-reported outcome (PRO) divided into three dimensions (walking/standing seven items, pain five items and social interaction four items). MOXFQ will be summarised as an index score covering the most important dimensions patients indicated after ankle fracture (e.g. pain, function and social interaction). Response options consist of a 5-point Likert scale ranging from zero to four. The MOXFQ index score will be calculated by summing the raw scores of the 16 items of the MOXFQ to a index score ranging from a minimum of 0 to a maximum of 100, where 100 represents the most severe health state.
Time frame
Measured as the change from baseline and after 6 and 12 weeksSecondary outcomes
1
Physical activity
The short-form International Physical Activity Questionnaire (IPAQ-SF) measure physical activity in five domains, including work-related physical activity, transportation, housework, leisure time and time spent sitting. Patients will be grouped into low, moderate and high physical activity levels depending on activities and time spent doing these activities.
Time frame
Measured as the change from baseline and after 6 and 12 weeks2
Health-related Quality Of Life (HRQOL)
HRQOL will be measured using the EuroQol five-dimension five-level questionnaire (ed-5d-5l)
Time frame
Measured as the change from baseline and after 6 and 12 weeks3
Ankle dorsiflexion
is measured using the knee-to-wall test, which measures ankle mobility in degrees of motion in standing.
Time frame
Measured as the change from baseline and after 6 and 12 weeks4
Ankle strength
is measured using the heel rise test. Patients perform as many single-leg heel raises at a cadence of one per second until fatigue or a maximum of 50 is reached. The test is performed on both legs, and normal function is recovered if the difference in heel raises between legs is 10% or less.
Time frame
Measured as the change from baseline and after 6 and 12 weeksOther outcomes
1
The index score of the Manchester-Oxford Foot Questionnaire (MOXFQ)
The index score of the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after randomisation is chosen as the primary outcome. Patients prefer MOXFQ, and it is a valid and reliable self-administered 16-item patient-reported outcome (PRO) divided into three dimensions (walking/standing seven items, pain five items and social interaction four items). MOXFQ will be summarised as an index score covering the most important dimensions patients indicated after ankle fracture (e.g. pain, function and social interaction). Response options consist of a 5-point Likert scale ranging from zero to four. The MOXFQ index score will be calculated by summing the raw scores of the 16 items of the MOXFQ to a index score ranging from a minimum of 0 to a maximum of 100, where 100 represents the most severe health state.
Time frame
Change from baseline to 6 and 12 months follow-up2
Physical activity long term
Physical activity will be measured in longer term using the short-form International Physical Activity Questionnaire (IPAQ-SF) and grouping patients into low, moderate and high physical activity levels.
Time frame
Change from baseline and after 6 and 12 months3
Health-related Quality Of Life (HRQOL) long term
Long term Health-related Quality Of Life (HRQOL) will be measured using the EuroQol five-dimension five-level questionnaire (ed-5d-5l)
Time frame
Baseline and after 6 and 12 months4
The index score of the Manchester-Oxford Foot Questionnaire (MOXFQ) in subgroups long term
The index score of the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after randomisation is chosen as the primary outcome. Patients prefer MOXFQ, and it is a valid and reliable self-administered 16-item patient-reported outcome (PRO) divided into three dimensions (walking/standing seven items, pain five items and social interaction four items). MOXFQ will be summarised as an index score covering the most important dimensions patients indicated after ankle fracture (e.g. pain, function and social interaction). Response options consist of a 5-point Likert scale ranging from zero to four. The MOXFQ index score will be calculated by summing the raw scores of the 16 items of the MOXFQ to a index score ranging from a minimum of 0 to a maximum of 100, where 100 represents the most severe health state and analysed in subgroups: males 18-39, females 18-39, males 40-59, females 40-59, males 60+, females 60+ and in treatment groups (surgical and non-surgical)
Time frame
Change from baseline and after 6 and 12 monthsSponsors and contacts
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Odense University Hospital
Lead sponsor
Aalborg University Hospital
Collaborator
Randers Regional Hospital
Collaborator
Aarhus University Hospital
Collaborator
Viborg Regional Hospital
Collaborator
Hospital of Southern Jutland, Aabenraa, Denmark
Collaborator
Slagelse Hospital
Collaborator
Bispebjerg Hospital
Collaborator
Hvidovre University Hospital
Collaborator
Herlev Hospital
Collaborator
National Hospital of the Faroe Islands
Collaborator
Hospital of South West Jutland, Esbjerg, Denmark
Collaborator
Køge Hospital, Denmark
Collaborator
Sygehus Lillebaelt
Collaborator
Source ClinicalTrials.gov