Bracing After Ankle Fracture

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.

• Physical activity [Time frame: Measured as the change from baseline and after 6 and 12 weeks]
• Health-related Quality Of Life (HRQOL) [Time frame: Measured as the change from baseline and after 6 and 12 weeks]
• Ankle dorsiflexion [Time frame: Measured as the change from baseline and after 6 and 12 weeks]
• Ankle strength [Time frame: Measured as the change from baseline and after 6 and 12 weeks]
• Hospital costs [Time frame: Measured as the total cost from baseline and after 12 weeks]
• Return to work [Time frame: From fracture and until date of return to work.]
• Index score (0-100) of the Manchester-Oxford Foot Questionnaire (MOXFQ) in subgroups [Time frame: Measured as the change from baseline after 6 and 12 weeks.]
• Adverse Events (AE) and Serious Adverse Events (SAE) [Time frame: Safety reporting for each patient will begin at baseline and after 6 and twelve weeks]