Active not recruitingOBSERVATIONAL

Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup

This study is about a hip replacement part called EUROSCUP Fixe. When people have hip problems like arthritis, fractures, or pain, a hip replacement can help them move more easily and reduce discomfort. This study helps doctors understand how well this specific hip cup works in real-world patients after their surgery. Researchers will be looking at information from people who have already received this hip replacement, as well as those who will receive it in the future. The main goal is to check its performance and safety for patients over time. It's part of an ongoing process to make sure medical devices are working as they should.

At a glance

Status

Active not recruiting

Sponsor

EUROS

Enrolment target

120

Start

27 Oct 2021

Estimated completion

01 Jul 2032

Hip Arthropathy Hip Osteoarthritis Hip Necrosis Hip Fractures Hip Dysplasia Hip Arthritis

What is this study about?

This research is focused on a specific part used in hip replacement surgery called the EUROSCUP Fixe. A hip replacement operation involves replacing a damaged hip joint with an artificial one. This is often done for people suffering from significant hip pain, stiffness, or difficulty moving due to conditions like arthritis, broken bones, or other hip problems. The main aim of a hip replacement is to help people move more easily and with less pain.

The EUROSCUP Fixe is designed to be one of the components used in total hip replacement surgery, both for people having their first hip replacement and for those needing a repeat operation. The study aims to gather information on how well this particular hip cup performs once it's been used in patients. This includes looking at how safe it is and how effective it is at helping patients recover and improve their quality of life.

This type of study is called 'post-market' because it happens after the device has been approved for use. It's a way for the manufacturer, EUROS, to keep track of their product's performance in many different patients over time. By collecting this information, they can ensure the device continues to meet safety standards and provides good results for patients who need hip replacement surgery.

Key takeaways

This study looks at the performance and safety of a specific hip replacement part called EUROSCUP Fixe.
It helps gather real-world information on how the device works after surgery for people with hip problems.
You don't need any extra tests or appointments if you participate; it uses your existing medical records.
Participation is for adults aged 18 to 80 who have already received this specific hip cup.
Joining helps improve our understanding of hip replacement technology for future patients.

Who may be eligible?

To be part of this study, you must have already received the EUROSCUP Fixe hip replacement. You also need to be aged between 18 and 80 years old. Most importantly, you must understand what the study involves and agree to take part.

You would not be able to join the study if there's a medical reason why the EUROSCUP Fixe was not suitable for you. Also, if you don't wish to take part or if you are considered a 'vulnerable subject' (which can include certain groups of people who might find it difficult to give their informed consent), you wouldn'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.

I have had, or am having, a hip replacement using the EUROSCUP Fixe.
I am aged between 18 and 80 years old.
I understand what the study involves.
I am happy for my existing medical information to be used for research purposes.

Answer every question to see your result.

What does participation involve?

This study is mainly about looking at information from people who have already had a hip replacement using the EUROSCUP Fixe. This means that for some participants, researchers will look back at their existing medical records. For others who are having the surgery now or in the future, researchers will collect information as they recover and continue their lives after surgery.

There are no special extra visits, assessments, or medications you would need to take specifically for this study. Your treatment and follow-up would be exactly as your doctor normally prescribes after hip replacement surgery. The study simply collects information from these routine appointments and your medical history. The total duration of your participation would depend on how long your doctor typically monitors your hip replacement, as the study uses these standard follow-up periods.

Potential risks and benefits

The potential benefit of this study is that it helps doctors and manufacturers understand more about how devices like the EUROSCUP Fixe perform over time, which can lead to better hip replacement options for future patients. For you as a participant, there are no direct medical benefits, as the study simply observes your journey after a standard procedure. Since there are no extra tests or interventions, there are no additional risks beyond those normally associated with your regular hip replacement surgery and recovery. Remember, you can always change your mind and withdraw your permission for your information to be used in the study at any time, without it affecting your medical care.

Locations (4)

Clinique Esquirol Saint Hilaire
Verified postcode
Agen, France
Clinique de L'Atlantique
Verified postcode
Puilboreau, France
Centre Hospitalier SECLIN
Verified postcode
Seclin, France
Clinique St Roch
Verified postcode
Toulon, France

Common questions

What is the EUROSCUP Fixe?

It's a part of an artificial hip joint used in hip replacement surgery.

Do I need to do anything extra if I join the study?

No, you just continue with your usual recovery and follow-up appointments after your hip replacement surgery.

Who can take part in this study?

People aged 18 to 80 who have received the EUROSCUP Fixe and agree to participate.

Will taking part affect my medical care?

No, your medical care will remain exactly the same whether you join the study or not.

Why is this study being done?

To check how well the EUROSCUP Fixe works and if it's safe for patients after it has been used in surgery.