Articular Pilon Fracture Trial (ACTIVE)

What is a pilon fracture?

A pilon fracture is a particularly severe break of the shin bone where it forms the ankle joint (see X-rays). It is usually caused by high-energy impact such as a fall from a height. 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 very large negative effect on a person’s quality of life.

 Pilon Fracture ankle

Why is this study needed?

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. Both the National Institute for Health and Care Excellence (NICE) and Consultant Orthopaedic Surgeons in the UK have 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.

What is the aim of the study?

The study aims 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 National Institute of Clinical Excellence as critical or important for this question.

What type of study is this?

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. We will do a qualitative study to explore issues around recruitment and monitor how well recruitment progresses in the first 12 months to make sure that the full trial is possible.

Who is being invited to take part?

We will include all adult patients (16 years or older) with a type C pilon fracture of the tibia where the treating surgeon believes the patient will benefit from surgical fixation.

Where is the study taking place?

NHS hospitals and specialist trauma centres in England, Scotland and Wales

ACTIVE GDPR Transparency Information Sheet (PDF , 510kb)

Privacy Notice: How we use your research data

Trial Details

Funder
National Institute for Health Research Health Technology Assessment Programme (15/130/84)

Sponsor
Hull University Teaching Hospitals

ISRCTN registration
ISRCTN98152560

IRAS project number
224065

Ethics Committee & Reference Number
Yorkshire & The Humber – Bradford Leeds REC 18/YH/0014

Start Date
01.09.2017

End date
31.08.2022

Contact Us

If you are interested in becoming a trial site (or are an existing one), Dr Matt Northgraves, matt.northgraves@york.ac.uk or call 01904321614.

If you have a media or scientific enquiry, Dr Stephen Brealey, stephen.brealey@york.ac.uk or call 01904 321357.

YTU Team

Stephen Brealey - Trial Manager

Matthew Northgraves – Trial Coordinator

Emma Turner – Trial Support Officer

Lydia Flett – Trial Support Officer

Ada Keding – Trial Statistician

Charlie Welch – Trainee Statistician

Belen Corbacho – Health Economist

Catriona McDaid – Co-applicant

Adwoa Parker – Co-applicant

David Torgerson - Co-applicant

Catherine Hewitt - Co-applicant

External Collaborators

Mr Hemant Sharma - Chief Investigator, Hull and East Yorkshire Hospitals NHS Trust

Professor Matt Costa - Professor of Orthopaedic Trauma Surgery, University of Oxford

Mr Nikolaos Giotakis – Orthopaedic Consultant Surgeon, Royal Liverpool and Broadgreen University Hospitals Trust

Professor Joy Adamson - Professor of Applied Health Research and Ageing, University of Newcastle

Miss Elizabeth Barron - Clinical Lead Physiotherapist, Hull and East Yorkshire Hospitals NHS Trust

Mr Graham Gedney - Patient and public co-applicant

Dr Arabella Scantlebury - Research Associate, University of Newcastle

Dr Lynne Stobbart - Senior Research Associate, University of Newcastle

Articular Pilon Fracture Trial ACTIVE logo

Hull and East Yorkshire Hospitals NHS Trust Logo

Medium size YTU logo (fits in right hand column)

Royal Liverpool and Broadgreen University Hospitals NHS Trust Logo

University of Oxford Logo

University of Newcastle Logo