Table I.

Trial objectives.

1	To determine the effectiveness of external fixation versus internal fixation for the treatment of Type C pilon fractures. This will be achieved through undertaking a parallel group multicentre RCT, using the primary outcome measure, the DRI which is a patient-reported outcome measure assessing patient function at 3, 6, 12, and 24 months. The primary timepoint is assessment of DRI at 12 months after randomization.
2	Undertake a 12-month internal pilot to obtain robust estimates of recruitment and confirm trial feasibility.
3	To explore barriers and facilitators during the pilot phase in order to optimize trial procedures and recruitment rates.
4	Undertake an economic evaluation to compare the cost-effectiveness of the two treatment options to determine the most efficient provision of future care and to describe the resource impact on the NHS for both treatments.

DRI, Disabilty Rating Index; RCT, randomized controlled trial.