Lay summary
Introduction: Determining the timing for weight bearing after ankle surgery is crucial for standardised rehabilitation. We aim to conduct a pilot trial to test the feasibility of a definitive RCT comparing Immediate Weight-Bearing (IWB) versus Delayed Weight-Bearing (DWB) in patients with ankle fractures who underwent Open Reduction Internal Fixation (ORIF).
Method: We will enrol 32 adult participants with stable fixation after ankle fractures and randomly assign them to IWB or DWB group. Participants in the IWB will bear full weight within 24 hours, while participants in the DWB will start full weight-bearing at 6 weeks. Outcome measures including Olerud and Molander Ankle Score (OMAS), Self-Reported Foot and Ankle Score (SEFAS), SF-36 health survey, time to return to work, and complications will be collected at 3- and 6-months post-surgery.
The pilot trial will assess recruitment rate, adherence rate, drop-out rate and sample size estimation for a large-scale RCT.