RecruitingPhase IIIInterventional

Through knee amputation compared to above knee amputation

Every day in the UK, many people have a leg amputated. Doctors always try to save as much of the leg as possible. If they can't save the lower leg, they usually do an amputation either through the knee joint or above it. This study, called HAMLET, wants to find out which of these two approaches is better for patients. It will compare things like quality of life, how well wounds heal, and how easily people can use an artificial leg or a wheelchair after surgery. We need more information to help patients and doctors decide which type of amputation might lead to the best results. The study will follow patients for two years to understand these impacts.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Hull University Teaching Hospitals NHS Trust

Enrolment target

386

Start

01 Mar 2025

Estimated completion

28 Feb 2028

Major lower limb amputation

What is this study about?

When someone needs to have their leg removed, it's a life-changing event. Doctors always aim to leave as much of the leg as possible, especially the knee joint, because it can make a big difference to how well someone recovers and uses an artificial leg, also known as a prosthetic. If the lower part of the leg can't be saved, surgeons face a choice: to remove the leg through the knee joint (a 'through-knee amputation') or higher up, above the knee joint (an 'above-knee amputation').

There are good reasons for both options. A through-knee amputation might make it easier to control an artificial leg or balance in a wheelchair. However, sometimes there can be problems with the wound healing. An above-knee amputation is also a common choice, but patients have told us about both good and bad experiences with both types of surgery. Currently, we don’t have enough clear information to say definitively which option is best for most patients.

This study, called HAMLET, aims to fill that gap. We will carefully compare patients who have a through-knee amputation with those who have an above-knee amputation. We will look at important things like their quality of life, how quickly they recover, whether they need more surgery, and how well they can walk and get around. The results will help doctors and patients make more informed decisions about which type of amputation is right for them in the future.

Key takeaways

This study compares two types of leg amputation: through-knee and above-knee.
It aims to find out which type leads to better outcomes and recovery for patients.
Participation involves being randomly assigned to one of the two surgery types.
You'll be followed for two years after surgery, with check-ups every four months.
Joining the study is voluntary and won't affect your medical care.
The findings will help improve future amputation decisions for patients and doctors.

Who may be eligible?

This study is looking for adults aged 18 or over who need a major leg amputation. This means you need to have part of your leg removed, and it's not possible to keep your knee joint. This also includes people who might have already had a lower leg amputation and now need to have more of their leg removed at or above the knee.

To join, you must be able to understand the study and agree to take part. You also need to be willing to come to follow-up appointments as planned.

You cannot join the study if doctors think you could have a 'below-knee' amputation (meaning your knee joint can be saved). You also can't join if either a through-knee or above-knee amputation isn't suitable for your health, if doctors expect you to live for less than six months, or if you need both legs amputated at the same time. You also shouldn't have difficulty completing questionnaires or coming to follow-up appointments.

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?
Do you need to have a major leg amputation where your lower leg cannot be saved?
Are you able to understand the study and willing to give your consent?
Are you able to attend follow-up appointments for two years?
Are you NOT able to have a below-knee amputation (meaning your knee joint cannot be saved)?
Are there no medical reasons preventing either a through-knee or above-knee amputation for you?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part in the HAMLET study, you will be put into one of two groups by chance – like flipping a coin – to have either a through-knee or an above-knee amputation. Neither you nor your surgeon will choose the type of surgery for the study; it will be decided randomly. This method helps us compare the two types of surgery fairly.

After your surgery, we will keep in touch and check on your progress every four months for two years. During this time, we will look at how your wound is healing, if you need any further operations, how your quality of life is, how well you are managing with rehabilitation (like learning to use an artificial leg), and your ability to walk. We will also consider the overall cost to the NHS. Some patients, if they agree, will also be invited for an interview to share their personal experiences and views about their amputation.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information we gather will be incredibly valuable. It will help future patients and healthcare teams make clearer choices about the best type of amputation surgery. Your care will not be negatively affected if you choose to participate or not; you will receive the surgery you need regardless. The surgeries examined in this study are already standard treatments in the NHS. As with all major operations, there are always possible risks, and your surgical team will fully discuss these with you before any procedure.

Locations (11)

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

Hull University Teaching Hospitals NHS Trust
City only
Hull, United Kingdom
Belfast Health and Social Care Trust
City only
Belfast, United Kingdom
Leeds Teaching Hospitals NHS Trust
City only
Leeds, United Kingdom
Mid and South Essex NHS Foundation Trust
City only
Westcliff-on-sea, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City only
Newcastle upon Tyne, United Kingdom
North Bristol NHS Trust
Unverified
Bristol, United Kingdom
Aneurin Bevan University Lhb
Unverified
Newport, United Kingdom
The Royal Wolverhampton NHS Trust
Unverified
Wolverhampton, United Kingdom
St George's University Hospitals NHS Foundation Trust
Unverified
London, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Unverified
Coventry, United Kingdom
University Hospitals of Leicester NHS Trust
Unverified
Leicester, United Kingdom

Common questions

What does 'randomly allocated' mean?

It means you'll be put into one of the two surgery groups by chance, like drawing lots or flipping a coin. This ensures the study is fair.

Will I still get my surgery if I don't join the study?

Yes, absolutely. The decision to have amputation surgery will still be made by your doctors, regardless of whether you choose to take part in this study.

How long will I be involved in the study?

If you join, we will follow your progress for two years after your surgery, with check-ins every four months.

Who is paying for this research?

The study is funded by a UK public body called the National Institute for Health and Care Research (NIHR), which supports health-related research.

What kind of questions will I be asked?

We will ask about your quality of life, how your wound is healing, how you are getting on with using an artificial leg or moving around, and if you've needed any further operations.

How to find out more

HAMLET Trial Team

ytu-hamlet-trial@york.ac.uk - Official trial record

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