RecruitingNAINTERVENTIONAL

TRabecular Metal Economic and Clinical Knee Trial

This study is called the TRabecular Metal Economic and Clinical Knee Trial. It aims to understand the differences between two methods of total knee replacement surgery: one where the new knee parts are fixed with cement, and another where they are not. Researchers will look at how well patients recover, if they are happy with their new knee, how long the new knee lasts, and if one method is more affordable for the NHS. This research will follow patients for 10 years, using special scores to measure knee function, pain, and how much patients 'forget' they even have an artificial knee. They'll also use wearable devices to track movement and see if one type of surgery leads to better daily activities like walking and climbing stairs.

At a glance

Status

Recruiting

Phase

Sponsor

NHS Greater Glasgow and Clyde

Enrolment target

144

Start

10 May 2022

Estimated completion

30 Jun 2035

Total Knee Replacement Orthopedics

What is this study about?

Imagine you need a new knee. There are different ways doctors can attach the new parts. This study is looking at two main ways: one uses a special cement to hold the new knee in place, and the other uses a type of implant that encourages your bone to grow into it, fixing it without cement. Both types of knees are made from a material called Trabecular Metal.

The main goal of this study is to find out if there's a real difference in how well these two methods work over a long period, up to 10 years. Doctors want to know which one helps patients move better, causes less pain, makes people feel more satisfied, and lasts longer. They also want to understand if one method is better value for money for the NHS.

To do this, the research team will ask patients to complete questionnaires about their knee and daily activities. They will also use special sensors worn by patients to measure how they move doing everyday tasks like walking and standing up. This helps them see if one type of knee replacement allows for more natural and easy movement.

Key takeaways

It compares cemented vs. uncemented knee replacements.
It follows patients for 10 years to see long-term results.
It aims to find out which method is best for patients and the NHS.
Researchers will use questionnaires, X-rays, and movement sensors.
Participation involves routine follow-up appointments.
You cannot choose which type of knee replacement you get in the study.

Who may be eligible?

This study is open to both men and women. There's no age limit. To join, you must be able to understand what the study involves and agree to take part by signing a consent form. You also need to be willing to come back to the hospital for all the follow-up appointments after your surgery.

You can join if you have arthritis in one knee and are getting a total knee replacement. If you have arthritis in both knees, you might still be able to join if your other knee already has a knee replacement that works well and isn't causing you pain.

You cannot join if you have certain other conditions that might make it hard for you to take part or recover properly. This includes if you need a second knee replacement surgery on an already replaced knee, or if you have problems with your feet, ankles, hips, or spine that affect how you walk. Certain nerve problems, or other health issues that might stop your knee from healing or make recovery difficult, would also prevent you from joining.

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.

Am I having my first total knee replacement for arthritis?
Am I able to visit the hospital for follow-up appointments for 10 years?
Do I understand what the study involves and can I give my consent?
Do I have any other significant health issues that might affect my recovery?
Is my other knee (if I have arthritis there) already fixed and pain-free?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will have either a cemented or uncemented total knee replacement. The choice of which type you receive will be made by chance, like flipping a coin. You will have regular check-ups at the hospital for up to 10 years after your surgery. These check-ups will involve answering questions about your knee, doing some movement tests, and having X-rays. You might also wear small sensors on your body to measure how you move during activities like walking or standing up. There will be no extra medication, but you will follow the standard recovery and rehabilitation plan for knee replacement surgery. The total duration of your involvement will be 10 years.

Potential risks and benefits

Taking part in this study could help doctors understand which type of knee replacement works best, potentially leading to better care for future patients. For you, the benefits are similar to having a standard knee replacement, aiming to reduce pain and improve movement. The risks are also the same as any total knee replacement surgery, such as infection, blood clots, or needing further surgery. 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.

Dept of Orthopaedics, Glasgow Royal Infirmary
Verified postcode
Glasgow, United Kingdom· Recruiting

Common questions

What is the study trying to find out?

This study wants to compare two ways of doing knee replacement surgery (with or without cement) to see which one works best, lasts longer, and has better results for patients and the NHS.

Will I get to choose if I have cement or not?

No, if you join the study, the choice between having cement or not will be made randomly, like drawing lots, to ensure fairness and good scientific results.

How long will I be part of the study?

You'll be followed for up to 10 years after your knee replacement surgery, with regular check-ups during that time.

What is 'Trabecular Metal'?

Trabecular Metal is the special material used for the new knee parts in this study. It's designed to be strong and, for the uncemented option, to encourage your bone to grow into it.

Will this study affect my standard medical care?

No, your medical care will be the same as if you weren't in the study. You'll still receive high-quality care for your knee replacement.

How to find out more

Mark JG Blyth, Mr

mark.blyth@ggc.scot.nhs.uk 01412114107 Official trial record

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