RecruitingNAINTERVENTIONAL

Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults

This study aims to discover the best way to fix a common type of broken thigh bone, specifically the lower part (distal femur), in older adults or those with other health concerns. We are comparing two methods: using a single metal support (Single Implant Fixation - SIF) or two metal supports (Dual Implant Fixation - DIF). Before launching a very large study, we first need to check if this research is practical. We want to see if we can successfully find and keep enough participants and if the treatments are safe and effective. Participants will be randomly assigned to receive either one or two supports for their broken bone and will have follow-up visits to check their healing and recovery.

At a glance

Status

Recruiting

Phase

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

Start

01 Sep 2025

Estimated completion

01 May 2030

Distal Femur Fractures

What is this study about?

This research is looking into how best to treat broken bones in the lower part of the thigh, called distal femur fractures. These types of breaks can be tricky, especially for older adults or people who have other health conditions, such as osteoporosis or diabetes.

At the moment, doctors might use one metal support (like a plate or a nail) to fix the bone, or sometimes they might use two. This study wants to find out if using two supports could lead to a better recovery for patients, such as less pain, getting back on their feet faster, and better overall healing, compared to using just one. It's really important to find out which method is most effective so doctors can provide the best care.

Before we can do a very big study, we need to do this smaller one to make sure everything runs smoothly. We're checking if it's possible to find enough people who want to take part and if they can stick with the study. We also need to test how we measure patient recovery and gather feedback from doctors. This will help us plan a bigger study in the future that can give us very clear answers about the best treatment.

Key takeaways

This study compares two ways of fixing broken thigh bones: one metal support versus two.
It's for older adults or those with other health conditions who have broken their lower thigh bone.
Participants will be randomly assigned to one of the two treatments.
The main goal is to see if a larger study is practical and to check the safety and effectiveness of the treatments.
Regular follow-up appointments will assess your bone healing and recovery.

Who may be eligible?

You might be able to take part in this study if you are 18 years or older and have recently broken the lower part of your thigh bone (a distal femur fracture) that can be fixed with plates and/or nails.

If you are under 60, you would also need to have other conditions such as osteoporosis (weak bones), obesity, certain types of complicated bone breaks, or diabetes. You must be able to understand and speak English, or have a translator available to help you.

You would not be able to join if your break is too severe, if you have other serious injuries, have a loose artificial joint nearby on the same leg, or if doctors think you wouldn't be able to keep up with the 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.

Do you have a recent break in the lower part of your thigh bone?
Are you 18 or older and either over 60, or between 18-60 with conditions like weak bones or diabetes?
Is your fracture suitable for fixing with plates or nails?
Can you understand English or have someone to translate for you?
Are you able to attend all follow-up appointments?
Do you not have a very severe open fracture or a loose artificial joint in the same leg?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly chosen to receive one of two types of surgery for your broken thigh bone: either a single metal support or two metal supports. This is like flipping a coin to decide, so neither you nor your doctor can choose which one you receive.

After your surgery, you will have regular clinic visits. During these visits, doctors will check how your bone is healing and how well you are recovering. This might include taking X-rays and possibly ultrasounds to get a closer look at your bone. You'll also be asked questions about your pain, how you're feeling, and your quality of life. The study will last for a certain period to track your recovery, and they will want to make sure you can attend all follow-up appointments.

Potential risks and benefits

Taking part in this study could potentially help improve care for future patients with similar broken bones by finding the most effective treatment. You might receive a treatment that could lead to a better recovery for you personally, but there's no guarantee. As with any surgery, there are risks involved, such as infection, bleeding, or issues with bone healing, regardless of whether you receive one or two implants. You are free to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Fraser Orthopaedic Institute
Verified postcode
New Westminster, Canada· Not yet recruiting
London Health Sciences Centre
Verified postcode
London, Canada· Recruiting

Common questions

What is a 'distal femur fracture'?

It's a break in the lower part of your thigh bone, just above your knee.

What's the difference between 'Single Implant' and 'Dual Implant' fixation?

Single implant means using one metal support (like a plate or a rod) to fix the bone. Dual implant means using two supports.

Will I get to choose which treatment I receive?

No, you will be randomly assigned to receive either the single or dual implant fix, like drawing lots or flipping a coin. This helps make the study fair.

Why is this study important?

It's important because it could help doctors find the best way to fix these types of broken bones, especially in older adults, leading to better outcomes for patients in the future.

What kind of follow-up will I need?

You'll have regular clinic visits to check your bone healing and recovery, which may include X-rays and ultrasounds, and answering questions about your health.

How to find out more

Emil Schemitsch, MD, FRCS(C)

emil.schemitsch@lhsc.on.ca 519-685-8500 Official trial record

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