A study protocol for a randomised trial of bracing after ankle fracture

Area of Science:

• Orthopedics
• Traumatology
• Rehabilitation Medicine

Background:

• Ankle fractures are common injuries requiring immobilization, often with foot-ankle braces (walkers).
• Emerging evidence suggests ankle stirrups may offer faster recovery without increased complications, and are preferred by patients.
• Current evidence on the non-inferiority of ankle stirrups compared to walkers is inconclusive.

Purpose of the Study:

• To assess if ankle stirrups are non-inferior to walkers in improving function and reducing pain after ankle fracture.
• To evaluate secondary outcomes including faster functional recovery, earlier return to work, and reduced healthcare costs.
• To provide evidence for informed clinical decision-making regarding ankle fracture bracing, considering patient preferences.

Main Methods:

• A two-phase, multicenter, pragmatic, non-inferiority randomized controlled trial.
• Inclusion of patients aged 18 years and older with surgically or non-surgically treated ankle fractures.
• Randomization of up to 1,400 patients, with sample size sufficient for subgroup analyses by sex, age, and treatment type.

Main Results:

• The trial is registered under NCT07163091.
• Data on functional outcomes and pain levels at three months post-fracture will be collected.
• Subgroup analyses will explore non-inferiority in specific demographic and treatment groups.

Conclusions:

• The study aims to determine the non-inferiority of ankle stirrups versus walkers for ankle fracture management.
• Findings will inform clinical practice and patient-centered care by comparing bracing options.
• The research is funded by Independent Research Fund Denmark.