Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
1400 participants
INTERVENTIONAL
2026-01-31
2029-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Investigate the Added Value of a Rehabilitation Brace in the Treatment at Home After a Fracture of the Ankle
NCT00284349
Preoperative Treatment of Malleolar Fractures
NCT02444468
Prognostic Factors Following Ankle Fractures
NCT03741556
Cast or Functional Ankle Orthosis After Ankle Fracture Surgery
NCT06559111
Ankle Fracture vs Ankle Fracture-Dislocation
NCT02198768
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
foot ankel brace (walker)
Walker: immobilisation during use
Foot-ankel brace (walker)
Walkers immobilise and stabilise the ankle during weightbearing.
Ankel stirrup
Ankel stirrup: active ankel dorsal and plantar flextion during use
ankel stirrup
Ankel stirrups are a patient preferred ankel brace that allow active ankle dorsal and plantar flexion during weightbearing while maintaining lateral stability.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ankel stirrup
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)
Walkers immobilise and stabilise the ankle during weightbearing.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Surgically or non-surgically treated ankle fracture
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aalborg University Hospital
OTHER
Randers Regional Hospital
OTHER
Aarhus University Hospital
OTHER
Viborg Regional Hospital
OTHER
Hospital of Southern Jutland, Aabenraa, Denmark
UNKNOWN
Slagelse Hospital
OTHER
Bispebjerg Hospital
OTHER
Hvidovre University Hospital
OTHER
Herlev Hospital
OTHER
National Hospital of the Faroe Islands
OTHER_GOV
Hospital of South West Jutland, Esbjerg, Denmark
UNKNOWN
Køge Hospital, Denmark
UNKNOWN
Sygehus Lillebaelt
OTHER
Odense University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bjarke Viberg, Phd
Role: STUDY_CHAIR
Odense Universitetshospital Ortopaedkirurgisk Afdeling
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Orthopedic Department, Hospital of Southern Jutland
Aabenraa, , Denmark
Orthopedic Department, Aalborg Universitets Hospital
Aalborg, , Denmark
Orthopedic Department, Aarhus University Hospital
Aarhus, , Denmark
Orthopedic Department, Bispebjerg Hospital
Copenhagen, , Denmark
Orthopedic Department, Hospital of South West Jutland
Esbjerg, , Denmark
Orthopedic Department, Herlev Hospital
Herlev, , Denmark
Orthopedic Department, North Zealand Hospital
Hillerød, , Denmark
Orthopedic Department, Hvidovre Hospital
Hvidovre, , Denmark
Orthopedic Department, Hospital Lillebaelt - Kolding
Kolding, , Denmark
Orthopedic Department, Zealand University Hospital - Køge
Køge, , Denmark
Orthopedic Department, Odense University Hospital
Odense, , Denmark
Orthopedic Department, Randers Hospital
Randers, , Denmark
Orthopedic Department, Slagelse Hospital
Slagelse, , Denmark
Orthopedic Department, Hospital Lillebaelt - Vejle
Vejle, , Denmark
Orthopedic Department, Viborg Hospital
Viborg, , Denmark
Surgical Centre, National Hospital of the Faroe Islands
Tórshavn, , Faroe Islands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10.46540/4308-00191B
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
OP_2497/OT_0001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.