Active not recruitingNAINTERVENTIONAL

A Study Using Metaphyseal Cones Versus a Cemented Stem Construct in Revision TKR

When a knee replacement needs to be redone, it's called revision knee replacement. This can be a tricky operation because removing the old replacement can leave a gap in the bone. Surgeons need to fill or support this gap so the new knee is stable. This study is comparing two main approaches: using extra cement to secure the new knee, or using a special device called a 'cone' which helps fill the bony gap and provides a stable base for the new knee replacement. The new knee could then have a shorter or longer stem. All these methods are currently used in the UK, but we don't know which one works best. This research aims to find out which method gives patients the best results over five years.

At a glance

Status

Active not recruiting

Phase

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Enrolment target

Start

21 Jun 2017

Estimated completion

30 Sep 2028

Total Knee Arthroplasty

What is this study about?

Knee replacement surgery is very common and usually works well. However, over time, some knee replacements don't last forever. They might wear out or become loose, meaning a patient needs another operation called a 'revision total knee replacement'. This second operation can be more complicated than the first. One of the main challenges is that when the old knee replacement is taken out, it sometimes leaves a large space or hole in the bone. For the new knee replacement to work properly and be strong enough for you to walk on, it needs to be very stable and secure in this space.

Surgeons use different methods to make the new knee replacement stable. One way is to use more cement than in the first operation to hold the new knee in place. Another method involves using a special device called a 'cone'. This cone fits into the space in your bone, and then the new knee replacement is cemented into the cone. Bone can then grow onto the cone, helping it become even more secure. The new knee replacement can also come with either a shorter or longer stem (a part that goes down into your thigh or shin bone).

All these different techniques are currently used in hospitals across the UK. However, doctors aren't yet sure which one is the most effective for patients. This study aims to gather information to compare these methods. By understanding which approach leads to better outcomes, doctors can make more informed decisions in the future, ultimately improving care for patients needing a revision knee replacement.

Key takeaways

This study compares different methods for a second knee replacement surgery.
The goal is to find the most effective technique for patients.
It looks at using extra cement or a 'cone' to secure the new knee.
Participants will be randomly assigned to one of the treatment options.
Your knee's progress will be followed for five years after surgery.
This research aims to improve care for future patients needing this type of surgery.

Who may be eligible?

This study is looking for adults aged 18 to 90 who are having their knee replacement redone for the first time at The Royal Devon and Exeter Hospital. This is for cases where the old knee replacement has worn out or become loose, but not if there's an infection.

You might be suitable if the new knee replacement needs a certain type of fit (called an AORI class 2 defect) in your thigh or shin bone, but not if the damage is very minor or very severe. You'll need to be generally healthy enough for the surgery, willing to come for follow-up appointments and X-rays, and able to participate in rehabilitation.

However, you won't be able to join if you refuse to take part, have an infection in your knee replacement (either before or found during surgery), have certain conditions that affect bone health, or if you're pregnant. Also, if your knee instability means a different kind of revision surgery is needed, or if you're only having your kneecap replaced, you won't be included.

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 having your knee replacement redone for the first time?
Is your current knee replacement loose or worn out, not infected?
Are you between 18 and 90 years old?
Are you having your surgery at The Royal Devon and Exeter Hospital?
Are you able to attend follow-up appointments and physical therapy?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be chosen by chance (like drawing lots) to receive one of three types of revision knee replacement: a new knee replacement secured with extra cement, a new knee replacement with a short stem cemented into a special cone, or a new knee replacement with a long stem cemented into a special cone. You won't get to choose which one you receive.

The study will take place at The Royal Devon and Exeter Hospital, including during your operation, in outpatient clinics, and during physiotherapy. After your surgery, the research team will monitor your progress for five years. This will involve filling out questionnaires about how your knee is feeling and working, having specific tests to check your knee function, and getting X-rays or scans of your knee. There are no additional medications involved in this study.

Potential risks and benefits

Taking part in this study could help doctors understand which revision knee replacement method works best, potentially improving future care for many patients. You will receive very careful monitoring of your knee's recovery. Like any surgery, there are always risks associated with the operation itself, but in this study, you will be receiving one of the standard treatments already used. There are no extra surgical risks by being in the study compared to not being in it. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

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

Royal Devon and Exeter Hospital
Verified postcode
Exeter, United Kingdom

Common questions

What is a 'revision total knee replacement'?

It's a second operation to replace a knee replacement that has worn out or become loose after the first surgery.

What is a 'cone' in this surgery?

A 'cone' is a special device fitted into a space in your bone to help secure the new knee replacement.

Will I get to choose which type of surgery I have?

No, if you join the study, the type of surgery you receive will be chosen randomly, like drawing names from a hat.

How long will I be followed after the operation?

The study team will check on your progress for five years after your surgery.

Are there any extra risks by being in this study?

No, you will be receiving a standard treatment already in use. There are no extra surgical risks compared to not being in the study.