Active not recruitingOBSERVATIONAL

Continuum Ceramic on Ceramic Bearing Post Market Clinical Follow-Up Study

This study is following people who have had a specific type of ceramic hip replacement system, called the Continuum Ceramic-on-Ceramic Bearing System. It's for patients undergoing their first hip replacement due to conditions like osteoarthritis, where the joint lining wears away, or other types of arthritis affecting the hip. The main goal is to see how well these hip replacements perform in real-world use after they've been made available. Researchers will monitor patients' pain levels, how easily they can move, and how long the hip implant lasts. They will also keep track of any problems that arise. The information gathered will help make sure this hip replacement system is both safe and works as expected for many years.

At a glance

Status

Active not recruiting

Sponsor

Zimmer Biomet

Enrolment target

203

Start

15 Sep 2010

Estimated completion

01 Sep 2025

Osteoarthritis Avascular Necrosis Inflammatory Arthritis Post-traumatic Arthritis

What is this study about?

This study is all about a specific kind of hip replacement system called the Zimmer Continuum Ceramic-on-Ceramic Bearing System. If you're having your first hip replacement because of conditions like osteoarthritis (which is wear and tear on your joints), or other types of arthritis, this study might be relevant to you. The key idea behind this particular hip replacement is that the ceramic parts rubbing together might wear down less than other materials, potentially making the hip last longer. This could mean fewer problems and a better result for patients in the long run.

Doctors taking part in this study want to see how well this ceramic hip replacement works in people over many years. They'll be looking carefully at several things: how much pain people have, how easily they can move their new hip, whether the hip replacement stays in place, and if any problems come up. To do this, they will use standard ways of checking your hip, take X-rays, and record any issues you experience. All of this information helps them understand the hip replacement's safety and how well it helps patients.

The study will follow 200 patients across six different hospitals for up to 10 years after their hip replacement surgery. This long follow-up allows researchers to get a really good picture of how the hip replacement performs over time. By carefully monitoring these patients, the hope is to confirm that the Continuum Ceramic-on-on-Ceramic Bearing System is a safe and effective option for people needing a hip replacement, potentially offering a long-lasting solution to hip pain and mobility problems.

Key takeaways

This study evaluates a specific ceramic hip replacement for its safety and how well it works.
It's for people having their first hip replacement for certain types of arthritis.
The ceramic design aims to reduce wear and potentially make the hip last longer.
You would be followed for up to 10 years with regular check-ups and X-rays.
The study helps ensure this hip replacement is a good long-term option for patients.

Who may be eligible?

To be considered for this study, you generally need to be between 21 and 75 years old and be having your very first hip replacement surgery. This surgery needs to be for specific reasons like osteoarthritis, where the joint wears down, avascular necrosis (when bone tissue dies due to lack of blood supply), inflammatory arthritis (like rheumatoid arthritis), or arthritis caused by a past injury. It's important that you haven't had a hip replacement in that hip before.

You also need to be able to understand what’s involved in the study and be willing to attend follow-up appointments and physical therapy. Your doctors will need to make sure your overall health allows you to safely participate, and you shouldn't have any conditions that might affect how your hip replacement heals.

There are also some reasons why you might not be able to join. For example, if you're pregnant, have certain neurological conditions, severe kidney problems, or issues that might cause your hip replacement to become unstable, you wouldn't be suitable. People who can't commit to the follow-up visits or who have problems with alcohol or drug misuse would also be excluded.

Quick self-check

Are you between 21 and 75 years old?
Are you having your very first hip replacement for arthritis or a similar condition?
Are you able and willing to attend regular follow-up appointments for up to 10 years?
Do you understand what the study involves and are you willing to give your consent?
Do you have good overall health and no conditions that might interfere with your hip healing?

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'll first have a detailed chat with the study team to make sure you understand everything involved and agree to participate – this is called informed consent. You'll then have your hip replacement surgery using the study's ceramic hip system.

After your operation, you'll have several follow-up visits with the study team. These appointments will happen at 6 weeks, 6 months, and then yearly for the first 3 years. After that, you'll have visits at 5, 7, and 10 years. During these visits, doctors will check your hip function, ask you about your pain and quality of life, take X-rays of your hip, and record any problems or changes. There's no specific medication involved in the study itself, but you'll follow your doctor's usual recommendations for pain relief and rehabilitation after surgery. The total duration of your participation, if you complete all follow-ups, would be 10 years.

Potential risks and benefits

Like any medical procedure, there are potential benefits and risks to consider if you join this study. A potential benefit is receiving a specific hip replacement system that aims to last longer due to its design, which could mean less wear and tear. You would also receive very close monitoring of your hip replacement over many years. However, there are also risks associated with any hip replacement surgery, such as infection, blood clots, or the need for further surgery. Taking part means you'll have more hospital visits than usual for follow-up appointments. Always remember, you have the right to leave the study at any time, for any reason, without it affecting the care you receive.

Locations (6)

HYKS-instituutti Oy
Helsinki, Finland
Dipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Università di Pisa
Pisa, Italy
Policlinico Tor Vergata
Rome, Italy
Glasgow Royal Infirmary
Glasgow, United Kingdom
Nuffield Department of Orthopaedics, University of Oxford
Oxford, United Kingdom
Southampton General Hospital
Southampton, United Kingdom

Common questions

What kind of hip replacement is being studied?

This study is looking at a specific ceramic-on-ceramic hip replacement system called the Zimmer Continuum Bearing System.

Why is this hip replacement considered special?

The ceramic materials used are thought to reduce wear and tear, which could potentially make the implant last longer than other types.

What will doctors be checking during the study?

They will monitor your pain levels, how well you can move your hip, how long the implant lasts, and if any problems occur using examinations, X-rays, and questionnaires.

How long will I be followed up if I join?

You'll have follow-up appointments for up to 10 years after your hip replacement surgery.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care.