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Ankle FractureBAFNCT07163091

Bracing After Ankle Fracture

A study testing ankel stirrup and Foot-ankel brace (walker) in people with Ankle Fracture and Rehabilitation, run by Odense University Hospital at 16 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ankle Fracture, Rehabilitation, Recovery
What is being tested?
ankel stirrup and Foot-ankel brace (walker)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,400 participants
Where
16 sitesin 2 countries
Study dates
23 Apr 2026to 30 Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years or older
  • Surgically or non-surgically treated ankle fracture

Who cannot join

  • Pathological fractures
  • Inadequacy to read or speak danish
  • Open fractures
  • Prolonged need for immobilisation (e.g. non-union or insufficient wound healing)
  • Inability to adhere to trial procedures (e.g. neuropathy or severe psychiatric disorder)
  • Restricted weightbearing
  • Uninterest in participating

Trial locations and contacts

16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Jonas A Ipsen, phd contact

+4523925264

Jonas.Ammundsen.Ipsen@rsyd.dk

Bjarke Viberg, Phd contact

bjarke.viberg@rsyd.dk

16 sites in 2 countries

Denmark15 sites, 15 recruiting

  • Orthopedic Department, Hospital of Southern Jutland

    Aabenraa, 6200

    Jonas A Ipsen, phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Nikolaj H Schmidt, MD phd

    Not yet recruiting

  • Orthopedic Department, Aalborg Universitets Hospital

    Aalborg, 9000

    Jonas A Ipsen, phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Rasmus A Elsøe, MD phd

    Not yet recruiting

  • Orthopedic Department, Aarhus University Hospital

    Aarhus, 8200

    Jonas A Ipsen, phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Jeppe Lange, MD phd

    Recruiting

  • Orthopedic Department, Bispebjerg Hospital

    Copenhagen, 2200

    Jonas A Ipsen, phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Arving G Von Keudell, MD phd

    Not yet recruiting

  • Orthopedic Department, Hospital of South West Jutland

    Esbjerg, 6700

    Jonas A Ipsen, phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Lars L Hermansen, MD phd

    Not yet recruiting

  • Orthopedic Department, Herlev Hospital

    Herlev, 2730

    Jonas A Ipsen, phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Peter Max Halschou-Jensen, MD phd

    Not yet recruiting

  • Orthopedic Department, North Zealand Hospital

    Hillerød, 3400

    Jonas A Ipsen, phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Jonas A Andersen, MD phd

    Not yet recruiting

  • Orthopedic Department, Hvidovre Hospital

    Hvidovre, 2650

    Jonas A Ipsen, phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Tazio Maleitzke, MD phd

    Not yet recruiting

  • Orthopedic Department, Zealand University Hospital - Køge

    Køge, 4600

    Jonas A Ipsen, phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Rasmus H Juul, MD phd

    Recruiting

  • Orthopedic Department, Hospital Lillebaelt - Kolding

    Kolding, 6000

    Jonas A Ipsen, phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Lars Rottwitt, MD phd

    Recruiting

  • Orthopedic Department, Odense University Hospital

    Odense, 5000

    Jonas A Ipsen, Phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Jonas A Ipsen A, phd

    Recruiting

  • Orthopedic Department, Randers Hospital

    Randers, 5930

    Jonas A Ipsen, phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Daniel Wæver, MD phd

    Not yet recruiting

  • Orthopedic Department, Slagelse Hospital

    Slagelse, 4200

    Jonas A Ipsen, phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Chris H Dreyer, MD phd

    Not yet recruiting

  • Orthopedic Department, Hospital Lillebaelt - Vejle

    Vejle, 7100

    Jonas A Ipsen, phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Claus T Varnum, MD phd

    Not yet recruiting

  • Orthopedic Department, Viborg Hospital

    Viborg, 8800

    Jonas A Ipsen, phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Marianne T Vestermark, MD phd

    Not yet recruiting

Other trials in Denmark

Faroe Islands1 site, 1 recruiting

  • Surgical Centre, National Hospital of the Faroe Islands

    Tórshavn

    Jonas A Ipsen, phd, +4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk

    Pætur m Holm, phd

    Not yet recruiting

About this study

Official title: Bracing After Ankle Fracture (BAF): a Randomised Multicenter Non-inferiority Trial Comparing Ankle Stirrups to Walkers on Pain, Function and Social Interaction for Adults After Ankle Fracture - Study Protocol

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.

Read the detailed description

Ankle fractures are the third most occuring fracture. After an ankle fracture, patients experience reduced ankle function and pain [3]. Also, evidence with moderate to high risk of bias indicate that immobilisation prolong patients recovery. However, high quality evidence are necessary for finite conclusions.

In Scandinavia, foot-ankle braces (walkers) are used to immobilise the fracture while healing. Even though patients acknowledge the need for immobilisation, a qualitative study of ten patients found that patients experienced difficulties in adhering to the recommendation of immobilisation after ankle fracture. A randomised controlled trial (RCT) by Smeeing et al. 2020 found that braces and elastic bands that allow more ankle movement than walkers did not lead to poorer functional outcomes (p=0.56), but may lead to a faster return to work (p = 0.02) without increased complications (p=0.63). The RCT was terminated when half the sample had been included, thus questioning the statistical power of the findings. Based on patient interviews completed during trial preparations we learned that patients preferred ankle stirrups as they allowed movement during use. The same patients also expressed an aversion to the walker, while being hesitant that ankle-supporting elastic bandages provided sufficient support.

Compared to the walker, ankle stirrups may better align with patient preferences while remaining non-inferior in restoring ankle-related outcomes such as pain and function.

Patients will be included in the orthopedic outpatient departments and randomised to a walker or an ankle stirrup. Randomisation will be in blocks to ensure that surgically and non-surgically patients are evenly distributed between groups and that each center will have an equal amount of intervention and control patients. Weightbearing will be unrestricted in both groups so the difference will be the brace (ankel stirrup or walker). Other variation will be a reflection of usual practice. The primary outcome is a validated score including pain, function and social interaction 12 weeks after ankel fracture. The sample size is calculated to 140 patients per each of six subgroups (males 18-39, females 18-39, males 40-59, females 40-59, males 60+, females 60+) randomisation stop when the smallest subgroup (females 18-39 years) reaches 140 or a maximum of 1400 has been included. Patients have been involved in designing the trial and a former ankle fracture patient serves a member of the steering committee.

Being tested
ankel stirrup, Foot-ankel brace (walker)
Keywords
ankle fracture, Brace, walker, ankle stirrup, intervention, RCT
Medical subject headings
Ankle Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ankel stirrupOther

    Ankel 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

    Walkers immobilise and stabilise the ankle during weightbearing.

Study groups in NCT07163091
Study groupRoleWhat they receive
foot ankel brace (walker)Active comparatorWalker: immobilisation during use
Receives: Other: Foot-ankel brace (walker)
Ankel stirrupExperimentalAnkel stirrup: active ankel dorsal and plantar flextion during use
Receives: Other: ankel stirrup

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Measured as the change from baseline and after 6 and 12 weeks

Secondary outcomes (8)

  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.

    Measured: Measured as the change from baseline and after 6 and 12 weeks

  2. Health-related Quality Of Life (HRQOL)

    HRQOL will be measured using the EuroQol five-dimension five-level questionnaire (ed-5d-5l)

    Measured: Measured as the change from baseline and after 6 and 12 weeks

  3. Ankle dorsiflexion

    is measured using the knee-to-wall test, which measures ankle mobility in degrees of motion in standing.

    Measured: Measured as the change from baseline and after 6 and 12 weeks

  4. 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.

    Measured: Measured as the change from baseline and after 6 and 12 weeks

  5. Hospital costs

    Hospital Costs will be measured from a hospital perspective with a time horizon of three months and include cost of procedures and in-hospital activities.

    Measured: Measured as the total cost from baseline and after 12 weeks

  6. Return to work

    Will be measured by asking patients what date they returned to work (full-time and part-time). Information on work-related physical requirements (e.g., blue-collar or white-collar workers) and usual employment status (e.g., retiree, unemployed, working) will also be collected.

    Measured: From fracture and until date of return to work.

  7. Index score (0-100) of the Manchester-Oxford Foot Questionnaire (MOXFQ) in subgroups

    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)

    Measured: Measured as the change from baseline after 6 and 12 weeks.

  8. Adverse Events (AE) and Serious Adverse Events (SAE)

    Adverse events are undesirable experiences that may occur during brace use as: i) skin irritation, blisters, or pressure sores due to poor fit, friction, or prolonged use, ii) swelling or increased edema, iii) pain or discomfort resulting from tightness, misalignment, or mechanical pressure, iv) delayed fracture healing due to excessive joint movement, v) Muscle atrophy or joint stiffness from immobilization, vi) reduced range of motion (ROM) and vii) removal of material (e.g., screws) due to discomfort or healing complications. Serious adverse events are complications requiring hospitalisation, surgical intervention, or posing a significant risk to the patient as i) death (e.g., an unexpected cardiac event occurring during the study period) ii) hospitalisation due to falls resulting from brace-related instability, iii) wound infection requiring inpatient treatment, potentially related to brace-induced i

    Measured: Safety reporting for each patient will begin at baseline and after 6 and twelve weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2025
  2. Study start23 Apr 2026
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07163091
Sponsor's protocol ID
OP_2497/OT_0001
Other IDs
10.46540/4308-00191B
Acronym
BAF
Status last verified
Apr 2026
First submitted
20 Aug 2025
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), will be provided to anyone who wishes to access the data.

Publications

  • Ipsen JA, Holsgaard-Larsen A, Abrahamsen C, Gundtoft PH, Costa M, Mikkelsen SS, Hrobjartsson A, Viberg B. A study protocol for a randomised trial of bracing after ankle fracture. Dan Med J. 2026 Mar 19;73(4):A09250748. doi: 10.61409/A09250748.

    PubMed 41978451

Questions about this trial

What is this clinical trial studying?

A study testing ankel stirrup and Foot-ankel brace (walker) in people with Ankle Fracture and Rehabilitation, run by Odense University Hospital at 16 sites in 2 countries.

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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Denmark, Faroe Islands. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jonas A Ipsen, phd (+4523925264, Jonas.Ammundsen.Ipsen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Index score (0-100) of the Manchester-Oxford Foot Questionnaire (MOXFQ) (time frame: Measured as the change from baseline and after 6 and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07163091, which also lists 1 linked publication.

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 29 Apr 2026.

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