RecruitingOBSERVATIONAL

Multicenter Mpact DM France

This important study is looking at a type of hip replacement called the MPACT DM cup. Doctors want to see how well these new hips perform over a long time – specifically, for 10 years after surgery. The main goal is to find out if the hip replacement lasts as expected. They will also be checking how well patients can move and use their new hip, if the implant stays safe and secure inside the body, and if there are any problems. This research will help doctors understand the long-term success of this hip replacement for people needing a total hip arthroplasty, which is the medical term for a full hip replacement operation.

At a glance

Status

Recruiting

Sponsor

Medacta International SA

Enrolment target

600

Start

05 Apr 2018

Estimated completion

01 Apr 2031

Total Hip Arthroplasty Survival, Prosthesis

What is this study about?

This study, called "Multicenter Mpact DM France," is focused on a particular type of artificial hip called the MPACT DM cup. When someone needs a total hip replacement (medically known as total hip arthroplasty), a new artificial hip is fitted. The doctors leading this research want to understand how good this specific MPACT DM cup is at helping patients over a long period, especially for 10 years after the surgery. They want to make sure it lasts well and gives patients a good quality of life.

The main thing the study is looking for is how long the hip replacement generally lasts. They will also be carefully checking other important things. This includes how much movement and function a patient gets back in their hip, how safely the new hip stays in place within the body, and if the different parts of the hip replacement remain stable and secure over time. They will use special scores and X-rays to measure these things.

By gathering all this information, researchers hope to get a clear picture of the long-term success of the MPACT DM cup. This will help doctors and patients in the future make informed decisions about the best hip replacement options available.

Key takeaways

Study focuses on the long-term success (10 years) of the MPACT DM hip replacement.
Aimed at first-time total hip replacement patients.
Involves regular check-ups and X-rays to monitor hip function and implant stability.
Excludes patients with certain health conditions or very high BMI.
Participation lasts for 10 years after surgery.

Who may be eligible?

To be considered for this study, you would generally need to be an adult between 18 and 80 years old who is planning to have their first total hip replacement. You should also be covered by some form of health insurance, like the NHS or a similar scheme, and be able to understand what the study involves.

There are several reasons why you might not be able to join. For example, if you need another organ transplant, have an active infection, or have certain muscle, nerve, or blood vessel problems that would make hip surgery unsuitable. You also can't take part if you have a very high body mass index (BMI over 40) or serious memory problems that would make it hard to follow the study's instructions.

The study also excludes pregnant or breastfeeding women, minors, and anyone already taking part in another medical research study. It's important that you live in an area where you can easily attend all necessary follow-up appointments.

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 80 years old?
Are you having a total hip replacement for the first time?
Do you have health insurance coverage (e.g., NHS)?
Do you understand what doing a study involves?
Do you *not* have a current infection or serious other health problems?
Is your BMI 40 or below?

Answer every question to see your result.

What does participation involve?

If you join this study, doctors will keep a close eye on your new hip for 10 years after your surgery. This will involve regular check-ups where they will ask you questions about your pain, how well you can move, and your general hip function. They will use a special scoring system, like the Harris Hip Score, to track your progress.

You will also have regular X-rays taken. These X-rays help the doctors see how the new hip is settling in, if it's stable, and if there are any changes in the bone around it. They'll be looking to make sure the implant is secure and not causing any problems. The study will also record any complications that might happen during or after your surgery, such as infections or if any parts of the new hip become loose. The full duration of your involvement in the study will be 10 years, with periodic follow-up appointments during that time.

Potential risks and benefits

Taking part in this study could potentially offer benefits, as you would receive regular, detailed monitoring of your hip replacement for 10 years, which could give you peace of mind. However, there are also potential risks involved, similar to any medical procedure, such as the general risks associated with hip replacement surgery and the possibility of complications like infection or the implant becoming loose. You will also need to attend a number of extra appointments for assessments and X-rays. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Centre Orthopédique Médico-Chirurgical de Dracy Le Fort
Verified postcode
Dracy-le-Fort, France· Recruiting

Common questions

What kind of hip replacement is being studied?

This study is looking specifically at one type of artificial hip replacement called the MPACT DM cup.

Why are they studying this hip replacement?

Doctors want to understand how well the MPACT DM cup performs and lasts over a long period, specifically 10 years, after a total hip replacement operation.

How long will I be in the study if I join?

If you join, you will be part of the study for 10 years after your hip replacement surgery. You will have regular check-ups during this time.

What will happen during the study check-ups?

During check-ups, doctors will ask about your hip's function and pain, and you will have X-rays to see how the hip replacement is looking inside your body.

Can I leave the study if I change my mind?

Yes, you have the right to leave the study at any point, and your decision will not affect your medical care.

How to find out more

Arianna Girardi

girardi@medacta.ch +41 91 696 60 60 Official trial record

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