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Not yet recruitingNAINTERVENTIONAL

Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip Arthroplasty

This study is comparing two types of hip replacement parts, specifically the “cups” in your hip joint that allow movement. Hip replacements are very common, but sometimes they wear out or need fixing within 10 years. One reason is that the plastic parts can wear down. Researchers have developed a new, stronger plastic material, called ECIMA, for these parts. This material is designed to be more durable and resistant to wear and tear over time. This study aims to find out if this newer material, when used in a specific type of hip cup (called 'dual-mobility'), actually reduces wear compared to the older material. The goal is to help make hip replacements last longer for people aged 55 to 80 who are having their first total hip replacement.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Enrolment target
96
Start
15 Nov 2025
Estimated completion
31 Aug 2036

What is this study about?

Hip replacement surgery is one of the most common operations in the UK. During this surgery, worn-out parts of your hip joint are replaced with artificial ones. One important part of a hip replacement is called the 'cup', which is fitted into your hip socket. Inside this cup, there's often a plastic lining that helps the joint move smoothly.

Unfortunately, these plastic linings can sometimes wear down over time, which can lead to problems and mean you might need another operation to fix or replace the hip implant. Roughly 10 to 20 out of every 100 hip implants need to be revised within 10 years, often because the plastic part has worn out. Doctors and scientists are always looking for ways to make these implants last longer for patients.

This study is looking at a new type of plastic material for these linings called ECIMA. It's designed to be much stronger and more resistant to wear than older plastics, and it also contains Vitamin E to help it last longer and not break down over time. Researchers want to compare ECIMA with the standard plastic used in a particular type of hip cup (called a 'dual-mobility cup') to see if it truly reduces wear and helps the hip replacement last longer. This research is important because if the new material works better, it could mean fewer revision surgeries for people in the future.

Key takeaways

  • This study compares two types of hip replacement materials to see which lasts longer.
  • It focuses on the 'cup' part of the hip replacement, which can sometimes wear out.
  • A new, stronger plastic material called ECIMA, enriched with Vitamin E, is being tested.
  • The goal is to reduce the need for repeat hip surgeries by finding more durable materials.
  • It is for people aged 55-80 having their first total hip replacement in France.
  • Participation involves extra follow-up appointments and imaging scans.

Who may be eligible?

This study is looking for men and women between the ages of 55 and 80 who are scheduled to have their first total hip replacement surgery. You would need to be generally healthy, with doctors expecting you to live for at least another five years after the surgery. You should also be covered by a social security healthcare plan in France and be able to speak French, as well as be willing to sign a consent form letting you take part.

There are also some reasons why you wouldn't be able to join. For example, if you have certain medical conditions that make surgery risky, or if you're already taking part in another study that might affect this one. You also couldn't take part if you are under legal protection (like guardianship) or deprived of your liberty.

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.

  1. Are you between 55 and 80 years old?
  2. Are you scheduled for your first total hip replacement?
  3. Do you speak and understand French?
  4. Are you generally healthy, with a life expectancy of more than 5 years?
  5. Are you covered by a social security healthcare scheme in France?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular appointments and tests over a period of time. This will involve imaging scans, like X-rays or other specific tests, to carefully check how your hip replacement is wearing down. You won't have to take any extra medication for this study, as it's looking at the hip replacement parts themselves rather than medicines. The total duration of your participation in the study will involve several follow-up visits after your hip replacement surgery, allowing researchers to track the long-term performance of the implants.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a hip replacement with a newer material that could, in theory, last longer, though this is what the study aims to find out. There are no additional medical risks beyond those typically associated with standard hip replacement surgery, which your surgeon will discuss with you. You will also have additional appointments and imaging scans above what normally follow a hip replacement. Remember, your participation is completely voluntary, and you can withdraw from the study at any time without it affecting your medical care.

Locations (1)

  • Hôpital Privé Jean Mermoz
    Verified postcode
    Lyon, France

Common questions

What is a 'dual-mobility cup'?

It's a specific type of socket used in hip replacements that has a special design inside, allowing for more movement and potentially a lower risk of the hip dislocating.

What does 'wear' mean in terms of a hip replacement?

It means the gradual rubbing away of the plastic parts in your hip joint over time, similar to how the sole of a shoe might wear down.

What is ECIMA?

ECIMA is a newer, stronger type of plastic material enriched with Vitamin E. It's designed to be more durable and resistant to wearing out than older plastic materials used in hip replacements.

Will taking part in this study affect my hip replacement surgery?

No, the surgery itself will be a standard hip replacement. This study is just looking at which specific type of 'cup' material is used during your operation and then tracking its performance afterwards.

Do I have to live in France to take part?

Yes, this is a French study, and you also need to speak French and be affiliated with the French social security system.

How to find out more

JEAN LANGLOIS, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Comparison of Wear Between Two Dual-mobility Acetabular Cups…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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