RecruitingOBSERVATIONAL

Mpact 3D Metal Monolit Study

This study investigates a new type of hip replacement component called the Mpact 3D Metal Monolith. Many people need hip replacements to improve their quality of life, and doctors are always looking for better ways to do this. This new hip cup is designed to be very strong and encourage your bone to grow onto it, making it more stable. The study will check how well people's hips work after surgery and how stable the new hip cup remains for up to five years. It's for adults aged 18 to 75 who need a hip replacement and aren't taking part in other trials.

At a glance

Status

Recruiting

Sponsor

Medacta International SA

Enrolment target

Start

28 Feb 2024

Estimated completion

01 Dec 2030

Total Hip Arthroplasty (THA)

What is this study about?

Hip replacement surgery, known medically as Total Hip Arthroplasty (THA), is a very common operation in the UK. It helps people with painful and damaged hips feel much better and move more easily. Doctors and engineers are always working to make these operations even better, by improving the artificial joints themselves, the tools they use, and the surgical techniques.

This study is focusing on a new type of hip replacement part called the Mpact 3D Metal Monolith. It's a special cup designed for your hip socket. This new cup has a unique outer surface with many tiny holes, like a sponge, which helps your own bone grow into it and attach firmly. This makes the hip replacement very stable, both straight after surgery and in the long-term. This design also aims to give you a better range of movement and reduce the chance of the hip joint coming out of place.

The main goal of this particular study is to keep track of how people who receive this new Mpact 3D Metal Monolith hip cup are doing. Doctors will collect information on how well their new hip works and how stable it is after two years. They will also look at how many of these hip replacements are still working well after five years. This information will help understand if this new design is as good, or better, than existing options.

Key takeaways

Looks at a new hip replacement cup (Mpact 3D Metal Monolith).
Aims for better stability and bone growth onto the implant.
Study tracks hip function and stability for 2 to 5 years.
For adults aged 18-75 needing a first-time hip replacement.
Involves regular check-ups and X-rays after surgery.

Who may be eligible?

This study is looking for people aged between 18 and 75 years old who need a first-time full hip replacement. You would also need to be covered by the French Social Security system or a similar healthcare plan, and capable of understanding and following the study's instructions.

There are several reasons why you might not be able to join. For example, if you have certain types of arthritis (like inflammatory arthritis), or if you've already had surgery on the same hip. People with active infections, severe hip bone problems, or certain muscle or nerve conditions that might affect recovery wouldn't be able to take part. Also, if you have very significant health problems that could make it hard to recover, a high body mass index (BMI over 40), or difficulty understanding the study requirements, you wouldn't be eligible. Lastly, if you're already in another research study, are under 18, or live somewhere too far to attend follow-up appointments, you couldn't participate.

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 between 18 and 75 years old?
Do you need your first full hip replacement?
Are you able to attend follow-up appointments?
Have you *not* had previous surgery on the same hip?
Do you *not* have inflammatory arthritis or an active infection?
Are you *not* currently in another research study?

Answer every question to see your result.

What does participation involve?

The study involves having a hip replacement operation using the Mpact 3D Metal Monolith cup. After your surgery, the doctors will regularly check how your hip is recovering and working. You will likely have clinical assessments where they examine your hip and ask about your pain and movement. You'll also have X-rays taken to see how the new hip joint is settling in. These check-ups will happen at specific times, with a close look at your progress at 2 years and a final check on how the hip cup is performing at 5 years after your operation. The total duration of your involvement in the study will be five years.

Potential risks and benefits

Participating in this study means you would receive a hip replacement with a new type of component that aims for better stability and bone growth, potentially leading to a longer-lasting and better-functioning hip. As with any surgery, there are always potential risks, such as infection, bleeding, or issues with the implant, though these are rare. The study is designed to closely monitor your health and the performance of the new hip. Remember, taking part in any study is completely voluntary, and you have the right to withdraw at any time without affecting your medical care.

Locations (3)

Clinique Brétéché
Verified postcode
Nantes, France· Not yet recruiting
Hôpital Lariboisière
Verified postcode
Paris, France· Not yet recruiting
Hôpital Cochin
Verified postcode
Paris, France· Recruiting

Common questions

What is a 'Total Hip Arthroplasty'?

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

What is special about the 'Mpact 3D Metal Monolith'?

It's a new hip socket cup with a special porous surface that encourages your own bone to grow into it, aiming for better stability and longer life.

How long will I be followed in this study?

The study will observe your hip's performance for up to five years after your surgery.

Will I have regular check-ups?

Yes, you'll have clinical assessments and X-rays to monitor your recovery and the hip's stability at specific times after your operation.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it will not affect your medical care.

How to find out more

Philippe Anract

philippe.anract@aphp.fr 01 58 41 30 38 Official trial record

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