Bracing After Ankle Fracture (BAF)

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.

Study Overview

• Status: Recruiting
• Conditions: Rehabilitation; Recovery; Ankle Fracture
• Intervention / Treatment: Other: Foot-ankel brace (walker); Other: ankel stirrup

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.

• Study Type: Interventional
• Enrollment (Estimated): 1400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
• Study Contact Backup: Name: Bjarke Viberg, Phd; Email: bjarke.viberg@rsyd.dk

Study Locations

• Denmark
  • Aabenraa, Denmark, 6200
    • Not yet recruiting
    • Orthopedic Department, Hospital of Southern Jutland
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Nikolaj H Schmidt, MD phd
  • Aalborg, Denmark, 9000
    • Not yet recruiting
    • Orthopedic Department, Aalborg Universitets Hospital
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Rasmus A Elsøe, MD phd
  • Aarhus, Denmark, 8200
    • Recruiting
    • Orthopedic Department, Aarhus University Hospital
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Jeppe Lange, MD phd
  • Copenhagen, Denmark, 2200
    • Not yet recruiting
    • Orthopedic Department, Bispebjerg Hospital
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Arving G Von Keudell, MD phd
  • Esbjerg, Denmark, 6700
    • Not yet recruiting
    • Orthopedic Department, Hospital of South West Jutland
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Lars L Hermansen, MD phd
  • Herlev, Denmark, 2730
    • Not yet recruiting
    • Orthopedic Department, Herlev Hospital
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Peter Max Halschou-Jensen, MD phd
  • Hillerød, Denmark, 3400
    • Not yet recruiting
    • Orthopedic Department, North Zealand Hospital
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Jonas A Andersen, MD phd
  • Hvidovre, Denmark, 2650
    • Not yet recruiting
    • Orthopedic Department, Hvidovre Hospital
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Tazio Maleitzke, MD phd
  • Kolding, Denmark, 6000
    • Recruiting
    • Orthopedic Department, Hospital Lillebaelt - Kolding
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Lars Rottwitt, MD phd
    • Sub-Investigator: Ane Simony, MD phd
  • Køge, Denmark, 4600
    • Recruiting
    • Orthopedic Department, Zealand University Hospital - Køge
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Rasmus H Juul, MD phd
  • Odense, Denmark, 5000
    • Recruiting
    • Orthopedic Department, Odense University Hospital
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Jonas A Ipsen A, phd
  • Randers, Denmark, 5930
    • Not yet recruiting
    • Orthopedic Department, Randers Hospital
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Daniel Wæver, MD phd
  • Slagelse, Denmark, 4200
    • Not yet recruiting
    • Orthopedic Department, Slagelse Hospital
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Chris H Dreyer, MD phd
  • Vejle, Denmark, 7100
    • Not yet recruiting
    • Orthopedic Department, Hospital Lillebaelt - Vejle
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Claus T Varnum, MD phd
  • Viborg, Denmark, 8800
    • Not yet recruiting
    • Orthopedic Department, Viborg Hospital
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Marianne T Vestermark, MD phd
• Faroe Islands
  • Tórshavn, Faroe Islands
    • Not yet recruiting
    • Surgical Centre, National Hospital of the Faroe Islands
    • Contact: Jonas A Ipsen, phd; Phone Number: +4523925264; Email: Jonas.Ammundsen.Ipsen@rsyd.dk
    • Principal Investigator: Pætur m Holm, phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: foot ankel brace (walker); Walker: immobilisation during use	Other: Foot-ankel brace (walker); Walkers immobilise and stabilise the ankle during weightbearing.
Experimental: Ankel stirrup; Ankel stirrup: active ankel dorsal and plantar flextion during use	Other: ankel stirrup; Ankel stirrups are a patient preferred ankel brace that allow active ankle dorsal and plantar flexion during weightbearing while maintaining lateral stability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 as the change from baseline and after 6 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 as the change from baseline and after 6 and 12 weeks
Health-related Quality Of Life (HRQOL)	HRQOL will be measured using the EuroQol five-dimension five-level questionnaire (ed-5d-5l)	Measured as the change from baseline and after 6 and 12 weeks
Ankle dorsiflexion	is measured using the knee-to-wall test, which measures ankle mobility in degrees of motion in standing.	Measured as the change from baseline and after 6 and 12 weeks
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 as the change from baseline and after 6 and 12 weeks
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 as the total cost from baseline and after 12 weeks
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.	From fracture and until date of return to work.
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 as the change from baseline after 6 and 12 weeks.
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	Safety reporting for each patient will begin at baseline and after 6 and twelve weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline to 6 and 12 months follow-up
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.	Change from baseline and after 6 and 12 months
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)	Baseline and after 6 and 12 months
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)	Change from baseline and after 6 and 12 months
Incremental cost per quality adjusted life year gain	cost-utility analysis will be completed alongside the clinical trial. Reporting will be from a societal perspective and with an one year timeframe. Utility will be measured in Quality Adjusted Life Years (QALY) by assigning values from the Danish eq-5d-5l reference set (i.e. each health state is assigned a value between -0.759 to 1.000 [40]. The follow-up period will be one year (t4). Costs will be collected from national registris. These, among others, include information on admissions, out-patient visits, home care services, contacts with general practitioners and other private healthcare professionals, prescription medication and welfare subsidies due to sick leave. Hours of informal care the last week patients receive from family and friends will be collected from patients at every follow-up (t1-t4). The reported amount will be assumed stable between time points. Valuation will based on the recommendations of the Health Technology Council and reported in euros (€) using the most	one year from baseline
carbon footprint of the trial	Carbon footprint of the BAF trial will be estimated by registrering activities associated with design, management and operation of the trial and summing the carbon of to estimate the overall carbon footprint (kgCO2e) using the Clinical Trial Carbon Calculator. Registered activities will be: cradle to gate estimate of ankle stirrups and foot-ankle braces, patients visits to hospital, mean of transportation to visits (car, public or bike, trial staff travel and mean of transportation to recruitments centers.	From baseline and after 6 and 12 weeks
Adverse Events and Serious Adverse Events (SAE) long term	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	Safety reporting for each patient will begin at baseline and after 6 and 12 months
Physical activity	A subgroup of patients will have their physical activity objectively evaluated using an accelerometer. The SENS Accelerometer is widely used and validated for young and older orthopedic patients. The accelerometer measures total accelerometer counts per day (a valid proxy for physical activity), rest time, standing time, active time (walking time, running, cycling), number of steps, movement intensity and sleep duration for four weeks. The total amount of accelerometer counts will be used to measure the level of physical activity between groups [39]. The accelerometer will be placed on the patients thigh at the day of randomization and followed for a minimum of 12 weeks.	From baseline and for a minimum of 12 weeks

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Aarhus University Hospital; Hvidovre University Hospital; Bispebjerg Hospital; Herlev Hospital; Aalborg University Hospital; Sygehus Lillebaelt; Slagelse Hospital; Viborg Regional Hospital; Randers Regional Hospital; Hospital of South West Jutland, Esbjerg, Denmark; National Hospital of the Faroe Islands; Hospital of Southern Jutland, Aabenraa, Denmark; Køge Hospital, Denmark
• Investigators: Study Chair: Bjarke Viberg, Phd, Odense Universitetshospital Ortopaedkirurgisk Afdeling

Publications and helpful links

General 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.

Helpful Links

• Link to study documents

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: August 20, 2025
• First Submitted That Met QC Criteria: September 1, 2025
• First Posted (Actual): September 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: RCT; intervention; Brace; ankle fracture; walker; ankle stirrup
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Ankle Injuries; Ankle Fractures; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Walkers
• Other Study ID Numbers: OP_2497/OT_0001; 10.46540/4308-00191B (Other Grant/Funding Number: Independent research fund Denmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Immediately following publication, no end date.
• IPD Sharing Access Criteria: Any researcher, affiliated to an established institution
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No