CompletedNot ApplicableInterventional

Ankle fracture fixation with or without a tourniquet

This study is looking into ankle fracture surgery. Some surgeons use a tourniquet (a tight cuff around the thigh) during the operation, while others don't. Using a tourniquet might reduce bleeding and make the surgery quicker, but it could also lead to more pain or other problems. Not using one might mean more bleeding during the operation. This first step is a smaller study to help doctors understand the best way to do a larger study later on. They want to find out how many people might join, what practical issues might come up, and how to make the bigger study successful. Participants will have their surgery as planned, but some will have a tourniquet used and others won't. They'll also complete a few short questionnaires.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

University of Warwick

Enrolment target

Start

07 Jul 2025

Estimated completion

31 May 2026

Primary fracture fixation surgery

What is this study about?

When someone breaks their ankle and needs surgery to fix it, doctors sometimes use a special cuff called a tourniquet around the thigh during the operation. Think of it like a tight band that temporarily stops blood flow to prevent bleeding in the ankle area during surgery. Some doctors believe this helps them see better and makes the operation quicker. However, other doctors wonder if using a tourniquet might cause more pain afterwards, or potentially lead to other issues like wound problems or blood clots.

Because there are different opinions and no clear answer yet, this study is a really important first step. It's designed to help us understand if it's practical to do a much larger study later on. This smaller 'feasibility' study will help us work out how many people are willing to take part, what questions they might have, and if the overall plan for a bigger study makes sense. It's all about making sure that if a larger study goes ahead, it will be well-organised and give us clear answers about the best way to perform ankle fracture surgery.

While this study won't give immediate answers about which method is best, it helps doctors prepare to find those answers in the future. By taking part, you'd be helping to improve care for many people who have ankle surgery down the line. It's about gathering information to improve medical knowledge and patient care for a common injury.

Key takeaways

This study compares ankle surgery with and without a tourniquet.
It's a 'feasibility' study, meaning it helps plan a larger, more detailed future study.
Participants will be randomly assigned to either the tourniquet or no-tourniquet group.
You'll complete a few short questionnaires after surgery.
Participation will help improve future ankle fracture care for others.
Your medical care will not be affected if you choose not to take part.

Who may be eligible?

This study is looking for adults aged 18 or over who are having surgery for a new ankle fracture (a broken ankle bone) that hasn't broken the skin. You would need to be having your surgery within two weeks of your injury at either University Hospital Coventry & Warwickshire or Royal London Hospital. You must be able to understand the study information and give your permission to take part.

There are a few reasons why you might not be able to join. For example, if your ankle fracture is a specific type called a "pilon fracture," or if you have certain long-term muscle, bone, or nerve conditions affecting the injured leg, or have had previous surgery on that leg. You also need to be able to speak and understand English, or have a family member who can translate for you.

They are also looking for a smaller group of patients and orthopaedic surgeons to have a chat (an interview) about their thoughts on the study. These interviews are open to those who took part in the main study, or those who decided not to.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having surgery for a new broken ankle (not a 'pilon' fracture and not an open wound) within two weeks of the injury?
Is your surgery taking place at University Hospital Coventry & Warwickshire or Royal London Hospital?
Can you understand English or have someone who can translate for you?
Do you not have any ongoing severe muscle, bone, or nerve conditions in the injured leg, or previous surgery on that leg?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the main study (the Feasibility RCT) for your ankle surgery, you'll be randomly put into one of two groups. One group will have the tourniquet used during their surgery, and the other group won't. It's like flipping a coin to decide, so neither you nor your doctor can choose. After your surgery, you'll receive all the usual care. You'll simply be asked to fill out a few short questionnaires about how you're doing: one day after surgery, then again three weeks, and finally three months after your operation. The study will follow your progress for a total of three months after your ankle surgery.

If you're asked to take part in the interview part of the study, you'll have a chat with a researcher that will last between 30 and 60 minutes. This is just to get your thoughts and experiences.

Potential risks and benefits

There won't be any direct personal benefit to you from taking part in this study. However, your participation will be incredibly valuable in helping doctors understand more about ankle surgeries and plan better studies in the future, ultimately improving care for everyone. The risks of your ankle surgery, such as pain, bleeding, blood clots, or problems with nerves and blood vessels, are the same whether you join the study or not, and whether a tourniquet is used or not. Doctors are trying to find out if using a tourniquet might increase certain risks, like more pain after surgery or problems with wound healing, or if not using one might lead to more bleeding during the operation. We don't know the answers yet, which is why this research is being done. The interview part of the study has no known risks. You are free to withdraw from the study at any time without affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Coventry and Warwickshire NHS Trust
City only
Coventry, England
Barts Health NHS Trust
City only
London, England

Common questions

What is a tourniquet?

A tourniquet is a tight cuff, similar to a blood pressure cuff, placed around your thigh during surgery to temporarily stop blood flow to your lower leg. This helps clear the surgical area.

Will I know if a tourniquet is used during my surgery?

Because this is a study, you won't get to choose. You'll be randomly assigned to either have one used or not, and you won't be told beforehand. This helps make the study fair.

How long does the study last for me?

You'll be part of the study for three months after your ankle surgery. This includes filling out a few short questionnaires at specific times during this period.

Do I have to take part?

No, taking part is completely your choice. Your decision won't affect the medical care you receive for your ankle.

Who is paying for this study?

This study is funded by the National Institute for Health and Care Research (NIHR), a major research funder in the UK.

How to find out more

Cristiana Huhulea

cristiana.huhulea@uhcw.nhs.uk +44 (0)24 7696 7476 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.