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Articular pilon fracture trial

Aim

The aim of this trial is to investigate the clinical and cost-effectiveness of internal plate fixation versus external fine wire fixation for the management of Type C closed pilon fractures of the distal tibia.

Background/method

Update August 2021 – ACTIVE has now closed to recruitment at the Queen Elizabeth Hospital

A pilon fracture is a severe break of the shin bone where it forms the ankle joint. It is usually caused by high-energy impact such as a fall from a height. These injuries are very difficult to treat and can have a very large negative effect on a person’s quality of life. Surgery is needed to fix the broken bone which can lead to serious infections, meaning more treatment is needed, including on occasion, amputation. Even where the fracture heals well, most patients develop arthritis in the joint. The injury is usually fixed by orthopaedic surgeons 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. There is genuine uncertainty among surgeons as to which is the preferable surgical option. NICE and Consultant Orthopaedic Surgeons have recommended that high-quality research is needed to find out whether internal or external fixation is best for treating pilon fractures and a better use of NHS money. This study will compare the outcomes of patients who receive internal plate or external fixation at 3, 6, 12 and 24 months follow-up. All adult patients (16 years or older) with a closed type C pilon fracture of the tibia will be included where the treating surgeon believes the patient will benefit from surgical fixation.

Chief investigator

Chief investigator

Mr Hemant Kumar Sharma

Principal investigator

Principal investigator

Ms Deepa Bose
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Current recruitment number