Not yet recruitingNAINTERVENTIONAL

Gait in Fixed Or Rotating Cementless Total Knee Arthroplasties

This study looks at two types of knee replacements: the Attune knee implant and the Triathlon knee implant. Many people need knee replacements because of arthritis, and new designs are always being developed to improve how well they work. The Attune implant was launched more recently, while the Triathlon has been used for longer. Both have shown good results in terms of how long they last. This research aims to find out if the Attune implant can help patients walk better on a treadmill, improve their overall knee function, and look good on X-rays compared to the Triathlon implant. 90 patients having knee replacement surgery will be randomly chosen to receive one of these two different implants.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Belfast Health and Social Care Trust

Enrolment target

Start

01 May 2025

Estimated completion

01 Dec 2027

Total Knee Arthroplasty Knee Osteoarthritis

What is this study about?

Each year, more and more people need knee replacements, often due to an ageing population, longer life expectancies, and increasing rates of obesity, which can worsen knee arthritis. Because of this, new knee implants and design features are regularly introduced. The goal is always to improve how patients feel and how well their new knee works. This study focuses on two of these implants: the Attune and the Triathlon.

The Attune knee implant was launched in 2013. Its designers intended it to offer better movement and reduce the wobbly feeling some patients report during daily activities, like going down stairs. The Attune implant that rotates was first used in 2016. The Triathlon implant, designed by another company, has been available since 2004. Both implants have a good track record, meaning they generally last a long time and lead to good results for patients.

Since the Attune knee is newer, there isn't as much information available about it compared to the widely used Triathlon implant. This study will help doctors understand if the Attune can lead to better outcomes for patients. They will compare how people walk on a treadmill (this is called gait analysis), ask patients how their knee feels and works (patient-reported outcomes), and look at X-rays to see the position and fit of the implants. Patients will be randomly assigned to receive either the Attune or the Triathlon implant for their surgery.

Key takeaways

This study compares two common knee implants: Attune and Triathlon.
It aims to see if one implant leads to better walking and knee function.
Patients will be randomly assigned one of the two implants during surgery.
Assessments include walking on a treadmill, X-rays, and patient questionnaires.
Both implants are already used successfully in many patients.

Who may be eligible?

This study is looking for people who are having their first knee replacement surgery for knee arthritis, specifically when the knee bends inwards slightly (known as varus deformity). You need to be under 65 years old to take part.

Before surgery, you must be able to walk at a speed of at least 4 kilometres per hour (about 30 metres in 30 seconds) and walk on your own or with just a walking stick. It's important that your hips, ankles, and other knee are not causing you significant pain that stops you from moving around easily. You also need to be able to speak and understand English well, and have access to a smartphone for filling out questionnaires and sending pictures.

Some reasons you wouldn't be able to join include if your knee bends outwards (valgus deformity), if you've had previous surgery on your lower leg or another joint replacement in your lower body, or if you have certain serious health conditions. You also can't take part if you would find it hard to follow the study instructions.

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 under 65 years old?
Is this your first knee replacement for arthritis?
Can you walk at least 30 metres in 30 seconds, on your own or with a stick?
Do you feel comfortable communicating in English?
Do you have hip, ankle, or other knee pain that limits your movement?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive either the Attune or the Triathlon knee implant during your knee replacement surgery. This is just like flipping a coin for fairness. Before your surgery, you'll have an assessment, including walking on a treadmill. After your surgery, you'll have follow-up appointments where you'll walk on the treadmill again, fill out questionnaires about how your knee feels, and have X-rays taken. You'll need to use a smartphone to complete some online questionnaires and send photos for virtual assessments of your knee movement. The study will continue for some time after your surgery, with specific follow-up visits and assessments.

Potential risks and benefits

Taking part in this study could help doctors better understand which knee implants work best, which might benefit future patients. For you, there's no guarantee of a better outcome from one implant over the other, as both are established and successful. All knee replacement surgery carries risks, such as infection, blood clots, or problems with the implant, and these risks apply regardless of which implant you receive. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

Musgrave Park Hospital
Verified postcode
Belfast, United Kingdom

Common questions

What is knee osteoarthritis?

Knee osteoarthritis is a common type of arthritis where the protective cartilage in your knee joint wears down over time, leading to pain, stiffness, and swelling.

What is a total knee replacement?

A total knee replacement, also called total knee arthroplasty, is surgery to replace damaged parts of your knee joint with artificial parts (implants) to relieve pain and improve movement.

Why are new knee implants being developed?

New knee implants are being developed to try to improve how well patients move, how stable their knee feels, and how long the artificial joint lasts, especially as more people need these surgeries.

What does being 'randomly placed' mean?

Being 'randomly placed' means that similar to drawing lots or flipping a coin, you will be assigned to receive either the Attune or the Triathlon knee implant by chance, not by choice or doctor preference. This ensures the study is fair.

Will I know which implant I received?

Yes, your medical team will inform you which implant was used during your knee replacement surgery as part of your standard medical care.

How to find out more

Nicola Gallagher

nicola.gallagher@belfasttrust.hscni.net 02895043746 Official trial record

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