Active not recruitingOBSERVATIONAL

Bone Fixation of Mpact Double Mobility Cup

This research study is investigating a specific type of hip replacement component called the Mpact Double Mobility cup. The main goal is to understand how well this hip cup stays fixed and stable inside the body over many years. This is important for ensuring the long-term success of total hip replacement surgery. Researchers will be using advanced imaging techniques, referred to as IMAGIKA technology, to carefully monitor the cup's position and stability within the bone. The study is for adults aged 18 to 80 who are having their first hip replacement. By observing how this particular component performs over time, doctors hope to gain valuable insights that can help improve future hip replacement procedures for many patients.

At a glance

Status

Active not recruiting

Sponsor

Medacta International SA

Enrolment target

150

Start

01 Jan 2014

Estimated completion

01 Jan 2030

Total Hip Replacement

What is this study about?

Hip replacement surgery is a common operation where a damaged hip joint is replaced with an artificial one. This can greatly improve movement and reduce pain for many people. One important part of an artificial hip is the 'cup', which is fitted into your pelvis (the large bone that connects your spine to your legs). This study is specifically looking at a type of cup called the 'Mpact Double Mobility cup'. The main aim is to see how well this cup stays secure and stable within your body for a long time after the surgery. Ensuring the hip cup remains firmly in place is key for the success and durability of your new hip joint.

The researchers want to understand the long-term 'fixation' of this particular cup. In simple terms, fixation means how well it's attached to your bone and doesn't move. To do this, they'll be using a special scanning technique called IMAGIKA technology. This allows them to get very detailed images of the hip joint and check if the cup is staying put as it should.

By following patients who have this specific hip cup over many years, doctors hope to gather important information. This information will help them learn more about how this type of hip replacement performs over its lifetime. Ultimately, the findings from this study could help improve the design and use of hip replacements, leading to better outcomes for patients undergoing hip surgery in the future.

Key takeaways

This study evaluates how well a specific hip replacement cup, the Mpact Double Mobility cup, stays fixed over time.
It uses advanced scanning technology called IMAGIKA to track the cup's stability in patients having their first hip replacement.
Participation involves having the hip replacement and attending long-term follow-up appointments for scans.
The study aims to improve understanding of hip replacement performance for future patients.
You must be aged 18-80 having your first hip replacement and commit to follow-up visits.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be having your very first total hip replacement and be between 18 and 80 years old. You also need to be able to attend all the scheduled follow-up appointments. This is important so the researchers can properly monitor your new hip over time.

There are several reasons why someone might not be able to join. For instance, if your hip problem is due to a broken bone in your thigh, or if you need extra bone added during your surgery (a bone graft), you wouldn't be eligible. Also, if you have ongoing infections, certain muscle or nerve problems, or diseases that would make it hard for you to recover full movement, you wouldn't be able to take part. Individuals with a very high body mass index (BMI over 40) or conditions affecting their memory or thinking (cognitive diseases) that might make it hard to participate in the study are also not included.

Finally, if you're already involved in another medical research study, or if you live in an area where it would be difficult for you to come in for your check-ups, you couldn't join. Pregnant or breastfeeding women are also excluded from this study.

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 having your first total hip replacement?
Are you between 18 and 80 years old?
Are you able to attend all planned hospital follow-up appointments?
Do you have a Body Mass Index (BMI) of 40 or less?
Are you NOT pregnant or breastfeeding?
Are you NOT involved in any other medical research studies?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would have your total hip replacement surgery as planned, with the Mpact Double Mobility cup being used. Your involvement would mainly consist of attending regular follow-up appointments over several years. During these visits, doctors would use the IMAGIKA scanning technology to check how securely the hip cup is fixed. There won't be any special medication for the study, and you will continue with any usual medication prescribed by your doctors. The full duration of your participation would depend on the long-term follow-up schedule defined by the study, which typically lasts several years to monitor the hip cup's stability over time.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that it helps doctors learn more about the long-term performance of this specific hip replacement cup, which could lead to better hip replacement practices for everyone in the future. As for risks, you would be undergoing standard hip replacement surgery, which carries its own risks, and these would be explained by your surgeon. The IMAGIKA scans are similar to other medical imaging and generally safe. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Clinique Générale
Verified postcode
Annecy, France
Orthéo - Espace Fauriel
Verified postcode
Saint-Etienne, France

Common questions

What is a 'Double Mobility cup'?

It's a special part of a hip replacement that goes into your pelvis, designed to offer more movement and stability than some other types of hip cups.

What does 'fixation' mean for my hip replacement?

Fixation means how well the artificial hip joint is secured to your bone. Good fixation means it stays firmly in place.

What is IMAGIKA technology?

It's a type of advanced imaging or scanning technology that allows doctors to get very detailed pictures of your hip joint to see how the cup is behaving inside your body.

Will I get special treatment if I join this study?

The main difference is that researchers will be closely monitoring your specific hip cup using advanced scans as part of the study. Your general medical care will remain the same as any hip replacement patient.

How often will I need to visit the hospital if I join?

You would need to attend regular follow-up appointments over several years. The exact schedule would be explained to you in detail before you decide to join.