Bracing After Ankle Fracture

Not Applicable

Not yet recruiting

• Conditions: Ankle Fracture; Rehabilitation; Recovery

• Registration Number: NCT07163091
• Lead Sponsor: Odense University Hospital

Brief 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. 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.

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 Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-20
• Study First Submitted QC: 2025-09-01
• Last Update Submitted: 2025-09-01
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Study Start: 2026-01-31
• Primary Completion: 2028-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Index score (0-100) of the Manchester-Oxford Foot Questionnaire (MOXFQ)	Measured as the change from baseline and after 6 and 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Physical activity	Measured as the change from baseline and after 6 and 12 weeks	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.
Health-related Quality Of Life (HRQOL)	Measured as the change from baseline and after 6 and 12 weeks	HRQOL will be measured using the EuroQol five-dimension five-level questionnaire (ed-5d-5l)
Ankle dorsiflexion	Measured as the change from baseline and after 6 and 12 weeks	is measured using the knee-to-wall test, which measures ankle mobility in degrees of motion in standing.
Ankle strength	Measured as the change from baseline and after 6 and 12 weeks	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.
Hospital costs	Measured as the total cost from baseline and after 12 weeks	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.
Return to work	From fracture and until date of 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.
Index score (0-100) of the Manchester-Oxford Foot Questionnaire (MOXFQ) in subgroups	Measured as the change from baseline after 6 and 12 weeks.	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)
Adverse Events (AE) and Serious Adverse Events (SAE)	Safety reporting for each patient will begin at baseline and after 6 and twelve weeks	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

Trial Locations

Locations (16)

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

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