A broken ankle bone called a pilon fracture is being fixed with two different surgical techniques in a head-to-head trial across NHS hospitals. Surgeons currently choose between an external frame—a metal cage outside the leg holding the bone in place with wires—and an internal locking plate screwed directly onto the bone. No one knows which method gives patients better long-term function, less pain, or fewer complications. The trial will randomly assign 250 to 334 adults with these severe fractures to one of the two procedures, then track their recovery using the Disability Rating Index and other measures for up to two years. If one technique proves clearly superior, surgeons will have evidence to standardise care, potentially reducing re-operations, shortening hospital stays, and improving how well patients walk and work again. The results could also save the NHS money by avoiding costlier second surgeries or prolonged rehabilitation. Both methods are already used in the NHS, so the findings can be implemented immediately without new equipment or training.
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DESIGN: A multi-centre, randomised, parallel group, superiority study to compare the clinical effectiveness and cost-effectiveness of external frame versus internal locking plate for complete articular pilon fracture fixation in adults. SETTING: NHS hospitals and specialist trauma centres. POPULATION: Patients with pilon fracture of the tibia. INCLUSION CRITERIA: Patients aged 16 years or older; with closed pilon fractures, classified AO 43-C which can be bi-lateral and patients with polytrauma; where the treating surgeon believes the patient will benefit from surgical fixation. EXCLUSION CRITERIA: Prior failed fixation; pathologic fracture; patient is/would be unable to understand instructions for treatment; more than 21 days of injury; pre-existing (pre-injury) skin condition which precludes open surgery. HEALTH TECHNOLOGIES BEING ASSESSED: INTERNAL FIXATION: 'Locking' plate fixation with screws. EXTERNAL FRAME FIXATION: Limited open reduction and articular fixation using screws and fine wire fixator. All randomised patients will receive the same standardised routine, written physiotherapy advice detailing the exercises they need to perform following surgery for their injury. OUTCOMES • Primary outcome: Disability Rating Index (DRI) at 12 months. • Secondary outcomes: 3, 6, 12 & 24 months: DRI; Olerud-Molander Ankle Score (OMAS); Health related quality of life (EQ5D-5L); Complications; Bone healing; Length of hospital stay; Resource use and work impact. SAMPLE SIZE: In order to detect a minimum clinically important difference of 8 points on the DRI with 90% power and 5% statistical significance, 133 participants per group are required. Accounting for 20% attrition at the primary endpoint of one year follow-up, the total recruitment target is 334 participants (167 per arm). Assuming two thirds of patients included in the primary analysis are followed up to two years, statistical power will be 75% for the group comparison at two years. In order to detect a minimum clinically important difference of 8 points on the DRI (SD 20) with 80% power and 5% statistical significance, 100 participants per group are required. Accounting for 20% attrition at the primary endpoint of one year follow-up, the total recruitment target is 250 participants (125 per arm). An implication of the revised recruitment target is that a higher proportion of patients will be followed up at the 24 month time-point. Assuming 80% of patients included in the primary analysis model are followed up for the revised target, statistical power will be 71% for the group comparison at two years. Recruitment will continue beyond the target of 250 patients if that is met until the end of the extended recruitment period on 31st October 2023. RANDOMISATION: Web-based randomisation will ensure allocation concealment (1:1). Randomisation will be stratified by centre with permuted blocks of random sizes. BLINDING: As with many surgical trials, it is not feasible to blind patients, surgeons or outcome assessors. Outcome bias will be mitigated somewhat by patients receiving surgical treatments of similar intensity. We will also collect data on patient preferences and account for whether patients received their preferred treatment in a secondary analysis. Analyses will be conducted by a statistician blind to treatment group. DIFFERENCE BETWEEN CURRENT & PLANNED CARE PATHWAYS: Both interventions are ‘standard care’ in the NHS. Follow-up protocols will vary among clinicians and units, although patients are routinely followed up for up to 1 year post surgery. PROJECT TIMETABLES: The proposed start date is 1st September 2017 with a 60 month study duration. The internal pilot will take place from months 7 to 18. With a 32 month extension to the project the study will now be 92 months in duration and end 30th April 2025. EXPERTISE IN TEAM: The team has expertise in the clinical area, the surgical techniques, trial design & delivery, qualitative research, statistics, health economics and patient experience.
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