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ACE Acetabular Cup UK Multi-centre PMCF Study

This study is checking how well a new hip replacement part, called the ACE Acetabular Cup System, performs over many years. A total hip replacement is a common operation to replace both the ball and socket of your hip, aiming to reduce pain and help you get back to your normal life. The ACE cup has a special coating to help it bond with your bone. Doctors can choose from different types of inner linings for the cup to suit each patient. This study will follow patients for 10 years after their surgery, looking at their progress through questionnaires, X-rays, and keeping track of any problems. It helps make sure new medical devices are safe and work well.

At a glance

Status
Recruiting
Sponsor
JRI Orthopaedics
Enrolment target
225
Start
06 Jun 2023
Estimated completion
01 Nov 2035

What is this study about?

When people have serious hip problems, a total hip replacement operation can be a really effective way to ease pain and help them get back to their active lives. This surgery involves replacing the natural hip joint with artificial parts, including a new ball and a new socket.

This particular study is all about a new type of hip socket called the ACE Acetabular Cup System. It's special because it has a coating that helps your bone grow onto it, making it more secure. Doctors also have a choice of different inner linings for this cup, which means they can pick the best option for each patient. The main goal of this study is to closely watch how well this new hip cup works for many years after the surgery.

Medical devices like this hip cup need to be carefully monitored to make sure they're safe and performing as expected over their lifetime. That's why this study will follow patients for 10 years. Researchers will regularly ask patients about their pain and how well they can move. They'll also review X-rays to see how the hip replacement is settling in and keep track of any problems or complications. This long-term monitoring helps ensure that the ACE Acetabular Cup System is a good, reliable choice for future patients.

Key takeaways

  • Tests a new hip replacement socket (ACE Acetabular Cup).
  • Aims to improve pain and movement for hip disease.
  • Follows patients for 10 years after surgery.
  • Uses questionnaires and X-rays to check progress.
  • Helps ensure new hip implants are safe and effective.

Who may be eligible?

To be part of this study, you would need to be an adult of 18 years or older who is planned to have a total hip replacement for the first time because of hip disease. You would also need to be able to understand the study and agree to take part.

However, there are some reasons why you wouldn't be able to join. For example, if your hip replacement is needed because of a recent accident like a broken hip, or if you are pregnant, then this study wouldn't be right for you. Also, if you need other types of hip replacement parts that aren't the specific combination being tested with the ACE Acetabular Cup, you wouldn't be able to participate. Lastly, if you are unable to follow the study plan for any reason, you wouldn't be suitable.

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.

  1. Am I at least 18 years old?
  2. Am I planning to have my first hip replacement for hip disease?
  3. Can I understand the study information and agree to take part?
  4. Is my hip replacement for a problem other than a recent break or accident?
  5. Am I not pregnant?
  6. Am I able to follow the study's instructions?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main part of your involvement will be having a total hip replacement operation using the specific ACE Acetabular Cup System. After your surgery, the research team will regularly check how you are doing over the next 10 years. This will involve filling out questionnaires about your pain and how well you can move and do daily activities. You will also have X-rays taken of your hip at certain times to see how the new joint is settling in. The research team will also keep track of any medical issues or complications that might happen after your surgery. There are no extra medications involved in this study, and the follow-up visits will likely be part of your routine hip replacement check-ups, with the added questionnaires and X-ray reviews.

Potential risks and benefits

Taking part in this study might offer you the potential benefit of being among the first to receive this specific hip replacement system that aims for good, long-lasting results. However, as with any surgery, there are always potential risks linked to general anaesthesia and the hip replacement procedure itself, such as infection or dislocation, which your surgeon will discuss with you. There are no additional risks specific to being in the study beyond those of the surgical procedure and follow-up. You are always free to discuss any concerns with your medical team and can withdraw from the study at any time without affecting the care you receive.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University Hospitals Sussex NHS Foundation Trust
    Verified postcode
    Worthing, United Kingdom· Recruiting

Common questions

What is a total hip replacement?

It's an operation to replace the damaged ball and socket parts of your hip joint with artificial ones to help relieve pain and improve your movement.

What is the ACE Acetabular Cup System?

It's a specific type of artificial hip socket used in hip replacement surgery, designed with a special coating to help it bond with your bone.

How long will I be followed in this study?

If you take part, you will be followed for 10 years after your hip replacement surgery.

Will I have more X-rays than usual?

You will have X-rays taken at specific times as part of the study, which will be reviewed to see how your new hip is doing.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and this will not affect the medical care you receive for your hip.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "ACE Acetabular Cup UK Multi-centre PMCF Study…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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