Active not recruitingOBSERVATIONAL

A Post Market Clinical Follow-up Study With the aneXys Cup

This study is looking at a new hip replacement part called the aneXys cup. The main goal is to check how safe and effective it is for people having their first hip replacement surgery. Doctors want to see how it performs over many years, from the short-term to the long-term, by studying 100 patients across three hospitals. This information will help them continuously ensure the product is safe and works well. They will follow up with patients at various times for up to 10 years to gather important clinical and X-ray information. This research helps make sure new medical devices meet important safety and quality standards.

At a glance

Status

Active not recruiting

Sponsor

Mathys Ltd Bettlach

Enrolment target

102

Start

05 Mar 2020

Estimated completion

01 Mar 2032

Arthroplasty, Replacement, Hip

What is this study about?

This study is all about a specific part used in hip replacement surgery, called the aneXys cup. When you have a hip replacement, one part of the new joint fits into your hip bone; this is the 'cup'. Doctors want to carefully watch how this particular aneXys cup performs in real-life patients over time.

The main aim is to understand how safe and effective the aneXys cup is, both shortly after surgery and many years later. This helps ensure that the device continues to meet high safety and quality standards. By collecting information from patients, researchers can monitor its performance and make sure it's doing its job well.

About 100 patients who are having their first total hip replacement will take part in this study across three different hospitals. The study will involve regular check-ups and X-rays for up to 10 years after surgery. This long-term monitoring is really important for understanding how new medical devices work in the body over a sustained period.

Key takeaways

The study looks at the aneXys hip cup's safety and performance.
It involves patients having their first hip replacement.
Participation includes regular check-ups and X-rays for up to 10 years.
The goal is long-term monitoring for safety and quality assurance.
You must be 18-75 years old and willing to attend follow-ups.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 75 years old and be having your very first hip replacement. This surgery should be needed because of conditions like arthritis in your hip, certain types of hip fractures, or bone tissue death in your hip. It's important that your doctors believe the new hip cup can be securely fixed in place during the operation. You should also be willing and able to attend all the follow-up appointments.

There are also reasons why you might not be able to join. For example, if you've already had hip replacement surgery on that hip before, if you have certain serious infections or cancers, or if you are pregnant, you wouldn't be eligible. Also, if there are concerns about your ability to follow the study instructions, you wouldn't be able to take part. Researchers also cannot include their own staff or relatives.

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?
Is this your first hip replacement surgery on that hip?
Are you having surgery for arthritis, a fracture, or bone death in your hip?
Can you attend regular follow-up appointments for up to 10 years?
Are you not pregnant and do not have certain serious illnesses like active infections or cancers?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be receiving the aneXys cup as part of your first total hip replacement surgery. After your operation, you'll have several follow-up appointments. These check-ups will happen at specific times: between 6 to 12 weeks, then at 6 months, 1 year, 2 years, 5 years, 7 years, and finally at 10 years after your surgery. There will also be an extra appointment at 3 years. These appointments will involve clinical examinations (where the doctor checks you over) and X-rays to see how your new hip joint is doing and how the cup is sitting. The total duration of your participation, if you complete all follow-ups, would be 10 years.

Potential risks and benefits

Taking part in this study means your hip replacement will be carefully monitored over many years, which could offer reassurance about the performance of your new joint. However, as with any surgery, there are general risks associated with hip replacement. Specific risks related to the aneXys cup itself are what the study aims to understand. You will receive the standard of care for your hip replacement, and there are no extra medications involved. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (3)

DRK Kliniken Berlin | Köpernick
Verified postcode
Berlin, Germany
DRK Kliniken Berlin | Westend
Verified postcode
Berlin, Germany
Universitätsklinikum Leipzig
Verified postcode
Leipzig, Germany

Common questions

What is the aneXys cup?

It's a specific part of a hip replacement joint that fits into your hip bone.

Why is this study being done?

It's to check how safe and well the aneXys cup works for patients over many years after hip replacement surgery.

How long will I be followed in the study?

You will have regular check-ups and X-rays for up to 10 years after your surgery.

Will I get special treatment if I join?

You will receive the standard hip replacement surgery, but your progress will be closely monitored, which is helpful for ongoing care.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, and it won't affect your medical care.