ACTIVE
Research type
Research Study
Full title
External frame versus internal locking plate for articular pilon fracture fixation: a multi-centre randomised controlled trial
IRAS ID
224065
Contact name
Hemant Sharma
Contact email
Sponsor organisation
Hull & East Yorkshire Hospitals NHS Trust
ISRCTN Number
98152560
Clinicaltrials.gov Identifier
Sponsor's Reference Number, R2177; EDGE system reference number, 104856
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
BACKGROUND
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 preferred surgical option. National Institute for Health and Care Excellence 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 better use of NHS money.
METHODS
This study aims to investigate the clinical and cost-effectiveness of internal plate fixation versus external fine wire fixation for the management of Type C pilon fractures.A randomised controlled trial will compare the outcomes of patients who receive internal plate or external fixation at 3, 6, 12 and 24 months follow-up. A qualitative study will explore recruitment issues.
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.
The study will take place in NHS hospitals in England, Scotland and Wales.
Lay summary of study results: Why did we do this trial?
A pilon fracture is a serious break of the shin bone at the ankle joint that often happens in falls from heights, motorcycle, road traffic or skiing accidents. This type of injury can impact on patient quality of life, cause arthritis and lead to money worries if people can’t work. Surgery to fix the broken bone can be done in two ways: internal fixation – using plates and screws that are placed under the skin; or external fixation – using a ring frame or cage outside the body. We wanted to find out which surgery is better for patients and offers good value for the National Health Service (NHS).What did we do?
Between March 2018 and October 2023 there were 255 adults enrolled into the study with a closed pilon fracture, where the bone was broken but the skin intact. Half of the patients had internal fixation and the other half had external fixation. We checked their health, surgical problems, bone healing, and use of healthcare for at least a year.What did we find?
The main health outcome asked patients twelve questions about how much their leg injury affected them. The overall score for the questionnaire ranged from 0 (no disability) to 100 (complete disability). After one year, the average scores were 32.1 in the external frame group and 35.6 in the internal plate group. Since the difference is small, neither surgery was clearly better for helping disability. There was some variation between groups in complications but these were low in numbers. Bone healing problems were similar for both types of surgery. There was only a 19% to 25% chance that external fixation was good value for money to the NHS mostly due to the cost of the external frame.What does this mean for adults with a pilon fracture?
After 12 months, neither surgery proved to be much better than the other. External fixation did not provide good value for money to the NHS. Doctors should let patients know about the trial results when choosing their treatment.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
18/YH/0014
Date of REC Opinion
13 Feb 2018
REC opinion
Further Information Favourable Opinion