Active not recruitingNAINTERVENTIONAL

AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study

This study is gathering information on a specific type of hip replacement called the AMIStem Hip System. It's a 'post-marketing' study, meaning it's happening after the hip system has already been approved and is being used in patients. The main goal is to see how well it works in everyday use for people who need a new hip. Doctors are checking its performance and carefully watching how patients recover after surgery. This includes understanding the benefits patients experience and any problems that might come up. It's for people with conditions like osteoarthritis, avascular necrosis, or a hip fracture, who are good candidates for this particular hip replacement.

At a glance

Status

Active not recruiting

Phase

Sponsor

Medacta International SA

Enrolment target

500

Start

01 Jan 2010

Estimated completion

01 Jan 2028

Osteoarthritis Arthritis Avascular Necrosis Fracture of the Femoral Neck or Head Congenital Hip Dysplasia

What is this study about?

This study is about a particular type of artificial hip called the AMIStem Hip System. When new medical devices like this hip replacement are approved for use, studies are often done afterwards to keep a close eye on how they perform in real patients. This is known as a 'post-marketing' study. It's a really important step to make sure the device is working as expected and to gather more information about its long-term success.

The main purpose of this study is to understand how well the AMIStem Hip System works for people who have had it fitted. Doctors and researchers will be looking at how patients recover after their hip replacement surgery, how much pain relief they get, and how their overall quality of life improves. They will also be checking for any potential problems or complications that might arise.

This information helps healthcare providers and the company that makes the hip system to understand its effectiveness and safety in a broader range of patients outside of initial trials. It adds to our overall knowledge of hip replacements and helps to ensure that patients receive the best possible care.

Key takeaways

Studies how a specific hip replacement (AMIStem Hip System) works in patients.
It's for people having hip surgery for conditions like arthritis or hip fractures.
Doctors will closely monitor your recovery and the hip system's performance.
You receive standard approved care; no new investigational drugs are involved.
Participation helps gather important information for future patient care.

Who may be eligible?

To be considered for this study, you would need to be a suitable candidate for a new hip replacement using the AMIStem Hip System. You'd also need to be willing and able to understand what the study involves and agree to take part, as well as attend follow-up appointments.

There are also some reasons why you might not be able to join. For example, if you have an active infection, or if your bones are still growing. Also, if you have severe muscle, nerve, or blood vessel problems in your leg, or other bone conditions that might stop the artificial hip from settling properly, you might not be able to participate. Finally, if you're unable to give your agreement or follow the study plan, you wouldn't be able to join.

Quick self-check

Am I generally a good candidate for a hip replacement?
Am I able and willing to attend follow-up appointments?
Do I understand and agree to take part in the study?
Do I have any active infections?
Do I have any severe muscle or bone problems in my leg?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study means that if you are having a hip replacement, your doctors will be using the AMIStem Hip System. After your surgery, doctors will regularly check on your progress and recovery. This usually involves appointments where they might ask you questions about your pain, how well you can move, and your general well-being. They might also do X-rays to check the hip replacement. You won't be given any experimental medicines; the focus is on how the hip system itself performs. The study doesn't ask you to do anything extra beyond what would normally be good medical practice after a hip replacement, but you will be asked to attend follow-up appointments for a period of time to allow doctors to collect information about your recovery and the success of the implant. The total duration of your involvement will be clearly explained by your doctor.

Potential risks and benefits

The potential benefit of joining this study is that your doctors will be closely monitoring your recovery after your hip replacement surgery, which could be reassuring. As the AMIStem Hip System is already approved and in use, you would be receiving standard care. However, as with any surgery, there are always potential risks, such as infection, blood clots, or issues with the hip replacement, which your surgeon will discuss with you. Taking part is entirely voluntary, and you are free to withdraw from the study at any time without it affecting your medical care.

Locations (2)

Uniklinik Balgrist
Zurich, Switzerland
The Elective Orthopaedic Centre (EOC)
Epsom, United Kingdom

Common questions

What is a 'post-marketing' study?

It's a study that happens after a medical device, like this hip replacement, has already been approved and is being used by patients. It helps doctors learn more about how it works in real-world settings.

Is the AMIStem Hip System a new, untested device?

No, it's an approved hip replacement system that is already available. This study is collecting more information on its performance over time.

Will I get special treatment if I join the study?

You will receive excellent care as you would normally, but your doctors will be carefully watching your recovery and collecting information about your hip replacement as part of the study.

What kind of conditions might lead someone to need this hip replacement?

Conditions like osteoarthritis (wear and tear of the joint), arthritis, avascular necrosis (where bone tissue dies due to lack of blood supply), certain hip fractures, or hip problems you were born with (congenital hip dysplasia).

Do I have to take any extra medication?

No, this study is about the hip replacement itself, not about testing new medicines. You'll only take medications your doctor prescribes for your usual care.