RecruitingNAINTERVENTIONAL

DIFFIR - Geriatric Distal Femur Fixation Versus Replacement

The DIFFIR study looks at the best way to treat a broken thigh bone just above the knee joint in people aged 65 and over. Currently, doctors often use plates and screws to hold the bone pieces together until they heal. However, this can lead to problems like the bone not healing or needing more surgery, and patients have to limit movement for a long time. Another option is a knee replacement, which allows people to walk sooner. This study compares these two approaches to see which one helps patients recover better, has fewer complications, and improves their quality of life. It’s important because there isn't clear guidance on which method is best.

At a glance

Status

Recruiting

Phase

Sponsor

Unity Health Toronto

Enrolment target

140

Start

01 Oct 2021

Estimated completion

31 Dec 2028

Distal Femur Fracture

What is this study about?

Imagine you're an older person and you've broken your thigh bone just above your knee. This can be a really tricky injury to treat. Doctors usually try to fix it by putting plates and screws in to hold the bone together so it can heal. However, for older people, especially if they are a bit frail, this method can sometimes lead to problems. The bone might not heal properly, or they might get an infection, and sometimes they need more surgery. Also, you have to keep your leg very still for weeks, which can be hard and lead to other health issues, making it difficult to get back to normal activities.

There's another way to treat this type of break, which is called a distal femoral replacement. This is a bit like a partial knee replacement where the damaged part of the bone is replaced with an artificial one. The big advantage of this is that people can often start walking much sooner after the operation, which could help them recover faster and avoid the problems of having to keep their leg still for a long time.

Currently, doctors aren't sure which of these two operations is better for older patients in the long run – which one leads to better movement and fewer problems, and which one is generally safer. This study, called DIFFIR, aims to find an answer. It will compare both methods systematically to see which one helps older people with these specific leg breaks get back on their feet better and with fewer issues. This is really important because it will help doctors choose the best treatment for their patients in the future.

Key takeaways

Compares two surgical options for broken thigh bone near the knee in older adults.
Aims to find out which surgery leads to better recovery and fewer problems.
Patients aged 65 and over with specific types of acute breaks can participate.
Taking part means agreeing to be randomly assigned to one of the two surgeries.
The study seeks to improve future treatment guidelines for this injury.

Who may be eligible?

This study is looking for men and women aged 65 and older who have broken their thigh bone just above the knee. The break needs to be a specific type – not an open wound and the bone needs to be broken in several pieces, but fixable by either surgery method. The injury must also be recent, within two weeks, and you must have been able to walk, even with help, before your injury. You should also be generally healthy enough to have surgery, and someone must be able to understand and sign the consent forms.

The study cannot include you if you have an infection near the broken bone, an open break, or if both of your thigh bones are broken. If you've had other major injuries at the same time, or if you have a broken bone caused by a disease like cancer (not just weakness), or if you've already had surgery on that part of your knee or hip, you won't be able to join. Also, if you have a diagnosis of dementia or any other medical reason making surgery unsafe, this study wouldn't be right for you.

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 65 years old or older?
Do you have a broken thigh bone just above one knee, and is it a recent injury?
Were you able to walk, with or without help, before your injury?
Do you have any active infections near the break, or has this bone been operated on before?
Does a doctor say you are generally healthy enough for surgery?
Are you able to provide your consent or have someone who can for you?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned, like flipping a coin, to receive one of two types of surgery for your broken thigh bone: either fixing it with plates and screws, or having a partial knee replacement. After your surgery, doctors will regularly assess your recovery, how well you can move your leg, and your overall health. They will also keep track of any problems you might experience. This will involve appointments and check-ups to monitor your progress over a period, though the exact duration isn't specified here, you can expect regular follow-ups to track your healing and function. You won't be given any new medications specifically for the study, as it's about comparing surgical procedures.

Potential risks and benefits

Taking part in this study could potentially offer benefits by helping find the best treatment for this type of fracture, which might lead to better recovery and fewer problems for you. However, as with any surgery, there are always risks involved, such as infection, bleeding, or the possibility that the bone doesn’t heal as expected. You will receive standard care, but the specific surgery you get will be decided by chance. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

St Michael's Hospital - Unity Health Toronto
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is a 'distal femur fracture'?

It's a break in your thigh bone (femur) that happens just above your knee joint.

What two treatments are being compared?

Doctors are comparing fixing the bone with plates and screws versus replacing part of the knee joint with an artificial one.

Why is this study important?

It will help doctors understand which surgical method works best for older patients with these specific breaks, leading to better care in the future.

Will I get to choose which surgery I have?

No, if you join the study, the type of surgery you receive will be chosen randomly, like drawing lots.

Who is funding this study?

The information provided does not specify the funding source for this study.

How to find out more

Cassandra Tardif-Theriault, BKin

cassandra.tardif-theriault@unityhealth.to +1416-864-6060 Official trial record

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