Statistical analysis
REGRESSION
Descriptive statistics will be used to summarise participants’ baseline characteristics and feasibility outcomes. All analyses will be conducted using a modified Intention-To-Treat approach. Whereby participants that are identified as post-randomisation exclusions (those participants who were identified as having an alternative diagnosis, and therefore failed the inclusion criteria will be excluded from the modified ITT analysis). All participants with a confirmed diagnosis will be included in the analysis. Estimates of outcome variability (e.g., standard deviation) were made with 95% confidence intervals to inform future sample size calculations. The primary efficacy outcome, ‘time in cast/off-loading device’, was analysed using a Cox Proportional Hazards (PH) regression model. Two covariates recorded at baseline were  included in the model: 1) off-loading device, removable or non-removable; and 2) Eichenholtz classification, stage 0 or stage 1 (based on clinical and X-ray findings).