RecruitingOBSERVATIONAL

Multigen Plus CCK and AMF TT Cones Follow Up Study

This study is checking a specific type of knee replacement implant, called Multigen Plus CCK, sometimes used with AMF TT cones. It's for people having their first knee replacement or needing a second one, especially if their knee feels unstable. We want to see how well these implants work over two years, looking at how people feel and how their knee looks on X-rays. This is a follow-up study for a device already in use, used in 68 patients across three European hospitals. Patients will have check-ups before surgery, during surgery, when they leave the hospital, and then at 3, 12, and 24 months afterwards.

At a glance

Status

Recruiting

Sponsor

Limacorporate S.p.a

Enrolment target

Start

21 Jun 2022

Estimated completion

01 Jul 2026

Total Knee Arthroplasty Revision Total Knee Arthroplasty

What is this study about?

This study is looking at a particular type of knee replacement operation. Sometimes, people need a knee replacement because their knee is very worn out or damaged. In some cases, they might even need a second knee replacement, for example, if the first one didn't work as well as hoped, or if they have instability in the knee joint.

The specific knee implant being studied is called the 'Multigen Plus CCK'. For some patients, doctors might also use extra small parts called 'AMF TT cones' with this implant. This study is designed to see how well these parts work together in helping people with unstable knee joints or issues with their knee ligaments, both for first-time knee replacements and for those needing a replacement of an older implant. Importantly, the decision for a patient to receive this particular knee implant is made by their surgeon as part of their standard care, completely separate from the decision to be part of this study.

The main goal of this study is to collect information over two years after the knee replacement surgery. Researchers will check on patients' progress, how their knee feels, and take X-rays to see how the implant is settling in. This helps doctors understand more about how well these specific knee replacement parts perform in real-world situations, which can lead to better care for future patients.

Key takeaways

The study looks at how a specific knee replacement, Multigen Plus CCK, performs.
It's for people getting a new knee or a replacement of an older one, especially for unstable knees.
Participants will have health checks and X-rays for two years after surgery.
The knee implant decision is made by your surgeon as part of your normal treatment.
The study aims to improve understanding of this implant in real-world use.
It involves 6 follow-up visits over a 24-month period after surgery.

Who may be eligible?

To be considered for this study, you would need to be 18 years old or older. You must also be someone for whom your surgeon has already decided that the Multigen Plus CCK knee replacement, possibly with AMF TT cones, is the right choice for your knee surgery. This decision about your surgery must have been made before you even think about joining the study, completely separate from it.

It's important that you are able to understand and agree to take part in the study by giving your written permission. You should also be able to come to all the scheduled appointments for the study.

You would not be able to join if you are under 18, or if you have any existing health problems that your doctor thinks might make it difficult to properly check the kneet replacement or might put your health at risk during the study. Women who are pregnant, breastfeeding, or planning to become pregnant also cannot take part. Additionally, if you had a knee replacement on your other knee within the last year and it didn't heal very well, you might not be eligible.

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 18 years old or older?
Has your surgeon already decided you will receive the Multigen Plus CCK knee replacement?
Can you attend all 6 study visits over two years?
Are you not pregnant, breastfeeding, or planning a pregnancy?
Do you have no other serious medical conditions that might interfere with the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a total of six visits. The first visit will be before your knee surgery. On the day of your surgery, there will be an 'intra-operative visit' which simply means information will be collected during your operation. When you are ready to leave the hospital after your surgery, there will be a 'discharge visit'. Following this, you will have follow-up visits at 3 months, 12 months, and 24 months after your operation.

At each of these visits, the study team will collect information about your knee. This will include doing standard checks on how your knee is feeling and working, and taking X-rays. They will also keep track of any unexpected medical problems or side effects, both minor and serious, that you might experience during the study. The total duration of your active participation, including all follow-up appointments, will be two years after your surgery.

Potential risks and benefits

Taking part in this study means doctors will be closely monitoring your new knee replacement, which could offer you more detailed insights into your recovery and the performance of your implant. However, as with any medical procedure, there are potential risks associated with knee replacement surgery itself, which are not directly caused by the study but are part of your treatment. The study mainly involves additional check-ups and X-rays beyond standard care. You have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (3)

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

Hospital Senhora da Oliveira in Guimarães
Verified postcode
Guimarães, Portugal· Recruiting
Saints Cyril and Methodius Hospital
Verified postcode
Bratislava, Slovakia· Recruiting
Royal Devon and Exeter Hospital
Verified postcode
Exeter, United Kingdom· Recruiting

Common questions

What is a 'knee arthroplasty'?

It's the medical term for a knee replacement operation, where a damaged knee joint is replaced with artificial parts.

What are 'AMF TT cones'?

These are small, extra parts that a surgeon might use with the main knee replacement implant to help make the knee more stable.

Why are they studying a device that's already in use?

This is a 'post-market' study, which means the knee replacement is already approved. Researchers want to gather more real-world information on how well it works and for whom, over a longer period.

How many people are in this study?

The study aims to include 68 patients across three hospitals in Europe.

Will I have different treatment if I join the study?

No, the decision to use this specific knee implant is made by your surgeon as part of your standard care, regardless of whether you join the study. The study involves extra monitoring and check-ups.

How to find out more

Francesca Citossi, CIS Manager Europe & APAC

francesca.citossi@limacorporate.com +39 335 1640260 Official trial record

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