Title: External frame versus internal locking plate for articular pilon fracture fixation: a multi-centre randomised controlled trial
Funder: Department of Health and Social Care

Abstract: DESIGN: Multi-centre RCT with internal pilot to evaluate the clinical & cost -effectiveness of internal plate fixation vs. external fine-wire fixation. SETTING: NHS hospitals and specialist trauma centres. POPULATION: Patients with pilon fracture of the tibia. INCLUSION CRITERIA: Patients aged 16 years or older; with unilateral closed pilon fractures, classified AO 43- C; within 21 days of injury; where the treating surgeon believes the patient will benefit from surgical fixation. EXCLUSION CRITERIA: prior failed fixation; pathologic fracture; lack of mental capacity to understand the trial or instructions for treatment. HEALTH TECHNOLOGIES BEING ASSESSED: INTERNAL FIXATION: 'Locking' plate fixation with screws EXTERNAL FRAME FIXATION: Limited open reduction and articular fixation using screws & 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: Manchester-Oxford Foot Questionnaire, DRI; 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. RANDOMISATION: Web- or telephone-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 & 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 amongst clinicians & units, although patients are routinely followed up for up to 1 year post surgery. PROJECT TIMETABLES INCLUDING RECRUITMENT RATE: 60 month duration - 36 month recruitment period. 23 centres have agreed to participate, with an estimated 345cases per year, representing 1035 patients over 3 years. Based on the number of cases available per centre per year and data from other surgical trials, we estimate 5 patients to be enrolled per centre per year. This is feasible given that on average centres treat on average 15 patients per year. 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.

Lay abstract: A pilon fracture is a particularly severe break of the shin bone where it forms the ankle joint. It is usually caused by high-energy impact such as fall from a height, motorcycle or skiing accident. These injuries are very difficult to treat, because the force needed to break the bone in this way also causes considerable damage to the flesh, blood supply and nerves around it. Surgery is needed to fix the broken bone. Serious infections can occur after surgery, meaning more treatment is needed, including more surgery and on occasion amputation. Even where the fracture heals well, over time most patients develop arthritis in the joint. This injury can have a large effect on quality of life. One study found that 20 months after surgery only a third of people were able to return to work and three quarters said that the injury caused them financial worries. Pilon fractures are treated by orthopaedic surgeons. The injury is usually fixed from the inside (under the skin) using a plate and screws (called ‘internal fixation’), or fixed from the outside using a ring frame or cage (‘external fixation’). The internal plate is cheaper than the external ring but the internal plate may increase the chance of the patient getting a deep infection which could lead to more surgery. Surgeons have different views about which is the best treatment and patients may find wearing an external frame around their leg makes it difficult to get around. The National Institute for Health and Care Excellence (NICE) has reviewed the research in this area and concluded it is not clear which of the two types of surgery to use. They recommended that high-quality research is needed to find out whether internal or external fixation is best for treating pilon fractures and better use of NHS money. In a survey of Consultant Orthopaedic Surgeons in the UK, this was ranked as one of the most important research questions in orthopaedic surgery. Our main aim is to find out which of the two types of surgery is better in treating the injury, and in terms of costs. We will measure outcomes which have been chosen by NICE as critical or important for this question. The best way to answer the question of which is the best type of surgery for patients is a randomised controlled trial. We will carry out a randomised controlled trial comparing the outcomes of patients who receive internal plate fixation with those who receive an external fixation at 3, 6, 12 and 24 months from when the patient takes part in the study. We will assess the effects of the two types of surgery on patients’ daily activities, quality of life, infection and unplanned further surgery. We will also investigate which procedure provides better value for money. It may be difficult to recruit enough people to take part because the injury is unusual. Young men who tend to have the injuries can be harder to involve in trials and surgeons and patients may have strong ideas about which treatments they prefer. Because of these challenges, we will monitor how well recruitment progresses in the first 12 months to make sure that the full trial is possible. The team undertaking the study has expertise in the clinical area, the surgical techniques, trial design and delivery, qualitative research, statistics, health economics and patient experience.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS