RecruitingOBSERVATIONAL

Effectiveness and Safety of Knee Cartilage Lesion Treatment Using CartiONE: 1-to-13 Year Follow-up.

This study is about a treatment called CartiONE for knee cartilage damage. It's investigating how effective and safe CartiONE has been for people who received the treatment up to 13 years ago. Researchers are looking at existing patient records from five European countries: Belgium, England, Greece, Poland, and Austria. They want to understand how patients have fared over time, specifically focusing on how well their knee cartilage has repaired and if there have been any problems. This will help doctors learn more about the long-term results of CartiONE and how it helps patients get back to their daily lives.

At a glance

Status

Recruiting

Sponsor

Cartilage Repair Systems BV

Enrolment target

100

Start

01 Mar 2024

Estimated completion

01 Dec 2025

Knee Cartilage Lesion

What is this study about?

Imagine your knee has a smooth, protective layer called cartilage. Sometimes this cartilage can get damaged, causing pain and making it hard to move. CartiONE is a special treatment designed to help repair this damaged knee cartilage. This particular study is looking back at patients who already received the CartiONE treatment between 2010 and 2023.

The main goal of this study is to see how well CartiONE has worked for these patients over a long period – from six months up to thirteen years after their treatment. They also want to check if the treatment was safe and if patients experienced any side effects. To do this, researchers will carefully review existing medical records, including details of the initial surgery, any follow-up appointments, and how patients felt about their knee recovery.

By gathering this information from patients in Belgium, England, Greece, Poland, and Austria, doctors hope to gain a much clearer picture of the long-term benefits and safety of the CartiONE treatment. This will help them decide how best to treat future patients with similar knee cartilage problems.

Key takeaways

This study is about a knee cartilage repair treatment called CartiONE.
It's a 'look-back' study, using existing patient records.
No new treatments or hospital visits are required for participants.
Researchers want to understand the long-term safety and effectiveness of CartiONE.
Data from patients in five European countries are being collected.
The results could help improve future treatments for knee cartilage damage.

Who may be eligible?

To be included in this study, you must have already had the CartiONE treatment for knee cartilage damage at least six months ago.

Also, the hospital where you were treated must have all your medical records available. This includes details about any previous knee surgeries, the CartiONE surgery itself, and any follow-up visits or additional treatments you might have had.

However, if your surgeon believes, for any reason, that you shouldn't be part of this study, then you won't be able to participate. This is to ensure the study is suitable and safe for everyone involved, even though it's reviewing past information.

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.

I had CartiONE treatment for my knee cartilage at least 6 months ago.
My hospital has all my medical records about my knee condition and treatment.
My treating surgeon thinks it's okay for my data to be included.
I had my CartiONE treatment between 2010 and 2023.

Answer every question to see your result.

What does participation involve?

If you are eligible for this study, you won't need to do anything new. This is because the researchers are looking back at information already collected from your medical records. You won't have any extra hospital visits, assessments, or need to take any new medication specifically for this study. Doctors will simply review the data that's already part of your standard care at the hospital where you had your CartiONE treatment. This review will cover information from your treatment date up to 13 years later, depending on when you had your procedure.

Potential risks and benefits

Since this study involves looking at your existing medical records rather than you undergoing new treatments or tests, there are no direct physical risks to you. There are no direct benefits to you as an individual, but your information will contribute to important medical knowledge. By understanding the long-term results of CartiONE, doctors may be able to improve treatments for future patients with similar knee issues. You would have the right to withdraw your permission for your data to be used at any time.

Locations (5)

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

UZ Ghent
Verified postcode
Ghent, Belgium· Recruiting
AZ Monica
Verified postcode
Antwerp, Belgium· Recruiting
MIRAI
Verified postcode
Warsaw, Poland· Not yet recruiting
University Hospitals Coventry & Warwickshire NHS Trust
Verified postcode
Coventry, United Kingdom· Not yet recruiting
Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Verified postcode
Oswestry, United Kingdom· Recruiting

Common questions

What is CartiONE?

CartiONE is a special treatment for damaged cartilage in the knee, using your own cells to help repair it.

Do I need to do anything if I'm in this study?

No, you don't need to do anything new. Researchers will look at your existing medical records.

What kind of information will they look at?

They'll look at your surgery reports, follow-up notes, and how your knee has been doing since the treatment.

Will this study benefit me directly?

Not directly, but the information will help doctors learn more about the CartiONE treatment for future patients.

How long will they look at my records for?

They will look at data collected from at least 6 months after your treatment, up to 13 years later.

How to find out more

Nele Vanparys

nvanparys@orteq.com +34665245704 Official trial record

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