Active not recruitingOBSERVATIONAL

Journey II BCS EU Observational Trial

This study is checking on a type of knee replacement called the Journey II BCS. It's for people who need a new knee because of joint problems like arthritis. Doctors will collect information from the medical records of 167 patients who get this knee replacement. They want to see how safe and effective the knee replacement is over a long period. This isn't a trial where you try a new treatment; it's about watching how patients do with a knee replacement that's already in use. You'll have follow-up visits for up to 10 years after your surgery, and doctors will look at how your knee is doing at those times.

At a glance

Status

Active not recruiting

Sponsor

Smith & Nephew Orthopaedics AG

Enrolment target

175

Start

01 Jan 2014

Estimated completion

01 Jun 2026

Degenerative Joint Disease

What is this study about?

Imagine you're getting a new knee because your old one is causing a lot of pain, perhaps from conditions like arthritis. This study is specifically designed to follow up on a particular type of knee replacement called the Journey II BCS. The main goal is to understand how well this knee replacement works in real life for ordinary patients, and to make sure it's safe and helpful over many years.

This isn't a study where you get a new or experimental treatment. Instead, it's about gathering information on a knee replacement that doctors are already using. Your medical team will simply collect details from your existing medical records about your surgery, your recovery, and how your knee feels in the months and years afterward. They'll use this information to learn more about the Journey II BCS system.

Understanding how patients do after this surgery is really important. It helps doctors and manufacturers confirm that the knee replacement continues to be a good option for people needing relief from joint pain. By participating, you're helping future patients benefit from this knowledge.

Key takeaways

The study observes a specific knee replacement, Journey II BCS.
It aims to confirm the safety and effectiveness over time.
Participation involves allowing access to your medical records for data collection.
No new treatments or procedures are part of the study.
You'll have follow-up visits for up to 10 years.
Your involvement helps improve understanding for future patients.

Who may be eligible?

To be part of this study, you would need to be having a complete knee replacement surgery using the Journey II BCS system. This surgery should be needed because of certain joint conditions like osteoarthritis or rheumatoid arthritis.

Also, you need to be an adult between 18 and 75 years old and be able to give your consent (permission) to join the study. You'd also need to be willing to come for the planned follow-up visits.

You wouldn't be able to join if you are over 75, or if you have certain health conditions that might make your knee replacement surgery or recovery more complicated, such as severe diabetes, or if your bones aren't strong enough to support the new knee.

Quick self-check

Are you having a total knee replacement with the Journey II BCS system?
Is your knee replacement due to conditions like arthritis?
Are you between 18 and 75 years old?
Are you willing to attend regular follow-up appointments after surgery?
Do you have any conditions like uncontrolled diabetes or very weak bones?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it means your doctors will collect information from your existing medical files. This information will be about your knee replacement surgery with the Journey II BCS system and how you recover afterwards. You won't be given any special medication for the study, nor will you have extra tests beyond what your doctor would normally recommend for your new knee.

The study involves follow-up visits over a long period. After your surgery, you'll have appointments at 3 months, 1 year, 2 years, 5 years, and then a final visit at 10 years. These visits are a normal part of monitoring a knee replacement, and the study will simply use the information gathered during these routine check-ups. The total time you'll be part of this study is 10 years.

Potential risks and benefits

There are no new medical treatments or procedures involved in this study, so there are no additional medical risks beyond those of your standard knee replacement surgery. The main benefit is that by allowing your medical information to be used, you're helping doctors learn more about the Journey II BCS knee replacement, which can assist future patients and improve care. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (5)

UZ Gent
Ghent, Belgium
University of Modena and Reggio Emilia
Modena, Italy
Sint Maartenskliniek
Nijmegen, Netherlands
Martina Hansens Hospital
Sandvika, Norway
North Hampshire Hospital
Basingstoke, United Kingdom

Common questions

What kind of knee replacement is being studied?

This study is looking at a specific type of knee replacement called the Journey II BCS.

Why is this study being done?

It's being done to check how safe and effective the Journey II BCS knee replacement is for patients over a long time.

Will I have to try new medicines or treatments?

No, this study only involves collecting information from your medical records; you won't receive any new medicines or treatments.

How long will I be in the study?

You will be followed for up to 10 years after your knee replacement surgery.

What kind of information will you collect?

Doctors will collect information from your medical files about your surgery, recovery, and how your new knee is doing at your regular check-ups.