Active not recruitingOBSERVATIONAL

PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty

This study aims to check the safety and performance of a hip replacement system called the Zimmer® Maxera™ Acetabular System. This system is used in people who are having a total hip replacement operation. The study will involve around 250 patients across different hospitals who are getting this particular hip replacement. Researchers want to make sure it works well and remains safe after it's been made available to patients. Conditions that might lead to needing this hip replacement and joining the study include different types of arthritis affecting the hip, such as osteoarthritis or rheumatoid arthritis, as well as problems like avascular necrosis or hip dysplasia. It's an important step to ensure medical devices continue to meet high standards for patient care.

At a glance

Status

Active not recruiting

Sponsor

Zimmer Biomet

Enrolment target

250

Start

01 Jan 2013

Estimated completion

01 Dec 2028

Rheumatoid Arthritis With Adequate Bone Quality Inflammatory Arthritis Osteoarthritis, Hip Avascular Necrosis Post-traumatic; Arthrosis Congenital Hip Dysplasia

What is this study about?

This study is all about making sure that a specific hip replacement system, called the Zimmer® Maxera™ Acetabular System, is both safe and works well for people undergoing a total hip replacement operation. This system has already been approved for use, and this study is a way for doctors and manufacturers to keep a close eye on how patients get on with it in the real world. They want to check its long-term performance and safety.

Total hip replacement surgery is a common operation where a damaged hip joint is replaced with an artificial one. This can help many people who suffer from severe hip pain and difficulty moving due to conditions like arthritis (such as osteoarthritis or rheumatoid arthritis), a condition called avascular necrosis where bone tissue dies due to lack of blood supply, or problems with the hip joint from birth (congenital hip dysplasia). This study specifically focuses on the 'cup' part of the hip replacement, which fits into your pelvis.

The main goal is to confirm that the Zimmer Maxera Cup, when paired with certain types of 'ball' components (BIOLOX® delta or BIOLOX® OPTION), continues to be a good and safe choice for patients. By carefully watching how almost 250 patients do with this hip replacement, researchers can gather valuable information to ensure the best possible care for people needing this type of surgery.

Key takeaways

The study evaluates an existing hip replacement system called Zimmer® Maxera™.
It's for people aged 18-75 needing a first total hip replacement for various hip conditions.
The goal is to confirm the long-term safety and performance of the hip system.
Participants will have regular follow-up appointments after their surgery.
This study helps ensure high standards for medical devices after they are on the market.

Who may be eligible?

To be considered for this study, you would need to be an adult between 18 and 75 years old and your bones should be fully grown. You would be a good fit if you're needing your first total hip replacement for one or both hips due to problems like osteoarthritis, certain types of inflammatory arthritis, avascular necrosis, or hip dysplasia. Importantly, you shouldn't have had a hip replacement or a procedure to fuse your hip joint together before.

There are also some reasons why you might not be able to join. For instance, if you have certain nerve or blood vessel conditions, poor bone quality, or bone tumours near the hip that could affect how the implant works. Also, if you’re a known alcohol or drug abuser, a prisoner, or unable to understand what’s involved in the study, you wouldn't be able to participate. The study needs participants who are able and willing to attend all follow-up appointments and understand the study requirements.

Quick self-check

Are you between 18 and 75 years old?
Are you needing your first total hip replacement?
Do you have a hip condition like arthritis or avascular necrosis?
Are you able and willing to attend follow-up appointments?
Do you have good bone quality in your hip?

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

What does participation involve?

If you decide to take part in this study, you will first need to go through an 'informed consent' process. This means you'll be given all the information about the study and have the chance to ask any questions before you agree to join. Once you've had your total hip replacement using the Zimmer® Maxera™ system, you'll need to attend scheduled follow-up appointments. These appointments are important for the researchers to check on your progress and the performance of your new hip. You'll also need to be willing to take part in any necessary rehabilitation or therapy after your operation.

Potential risks and benefits

Taking part in this study could help researchers gather more information about the long-term safety and effectiveness of the Zimmer® Maxera™ hip system. This information can benefit future patients needing hip replacements. As with any surgery, there are potential risks involved with a hip replacement, such as infection, pain, or issues with the implant, which your surgeon will discuss with you. These are general risks associated with hip replacement surgery, not necessarily specific to the study itself. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (8)

The Mater Hospital, Concord Hospital
Sydney, Australia
UZ Leuven
Pellenberg, Belgium
Center Maisonneuve-Rosemont Hospital
Montreal, Canada
Jokilaakson terveys oy
Jämsä, Finland
Centre Hospitalier de Perpignan
Perpignan, France
Reinier de Graaf Groep
Delft, Netherlands
Hospital Son Llatzer
Palma de Mallorca, Spain
Royal Liverpool and Broadgreen University Teaching Hospitals
Liverpool, United Kingdom

Common questions

What is the purpose of this study?

The study aims to check how safe and well a specific hip replacement system, the Zimmer® Maxera™, performs in patients undergoing total hip replacement.

Who can join this study?

Adults aged 18-75 needing their first total hip replacement for conditions like various types of arthritis or avascular necrosis, who can attend follow-up appointments.

What kind of hip problems are included?

The study includes people with osteoarthritis, inflammatory arthritis, rheumatoid arthritis, avascular necrosis, and congenital hip dysplasia.

Will I get a new type of hip replacement?

No, this study is about a hip replacement system (Zimmer® Maxera™) that is already available to patients. It's about monitoring how it performs.

What will happen if I join?

You'll have your hip replacement, participate in the consent process, and then attend scheduled check-ups for doctors to see how your new hip is working.