Active not recruitingNAINTERVENTIONAL

Investigation to Determine Safety of Taperloc Stems With BioGuard Coating When Used in Cementless Total Hip Arthroplasty

This study is exploring a new kind of hip replacement designed for people with hip arthritis. It’s called a Taperloc stem with BioGuard coating and an Exceed ABT Taperfit cup, which are meant to be fitted without cement. The main goal is to check how safe these new hip replacement parts are. Researchers will compare them with standard hip replacements to see if they work well and are safe for patients. Participating in the study would involve having one of these hip replacements and attending follow-up appointments. The study is designed to help doctors understand if this new technology offers a good and safe option for hip replacement surgery.

At a glance

Status

Active not recruiting

Phase

Sponsor

Zimmer Biomet

Enrolment target

Start

01 Oct 2013

Estimated completion

01 May 2025

Osteoarthritis of Hip

What is this study about?

This study is looking into a new type of hip replacement called Taperloc stems with BioGuard coating and Exceed ABT Taperfit acetabular cups, which also have a BioGuard coating. When someone needs a hip replacement, one common way to fix the new parts in place is using a special cement. However, these new hip parts are designed to be used without cement, meaning they rely on your bone to grow onto them and hold them firmly.

The main purpose of this study is to check how safe these new hip replacement components are. The BioGuard coating is a new feature, and the doctors want to make sure it's a good option for people needing hip surgery due to osteoarthritis, which is a type of wear-and-tear arthritis in the hip joint.

By comparing this new hip replacement system with standard ones, the study aims to gather important information. This information will help doctors understand if these new parts are safe and effective, potentially offering another good choice for future patients undergoing hip replacement surgery.

Key takeaways

This study is testing a new, cementless hip replacement with a special BioGuard coating.
It's for people aged 40-80 who need their first hip replacement due to arthritis.
The main goal is to check how safe this new hip replacement is.
You would receive either the new or a standard hip replacement.
Participation involves follow-up visits to check your recovery and the hip implant.

Who may be eligible?

This study is looking for people aged between 40 and 80 who need their first hip replacement because of arthritis. You should be in generally good health for your age and be able to understand and follow instructions from the doctors and nurses. It’s also important that you're willing to come back for follow-up appointments after your surgery.

There are some reasons why you wouldn't be able to join the study. For example, if you're younger than 40 or older than 80, or if you already have an infection. You also can't be in the study if you have certain conditions like Parkinson's disease, severe diabetes that affects blood flow to your leg, or if you're pregnant. People with a very high BMI (over 40) or those taking medicines that suppress their immune system would also not be able to participate.

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 40 and 80 years old?
Are you having hip replacement surgery for the first time?
Do you have arthritis in your hip?
Are you generally healthy for your age?
Do you think you can attend follow-up appointments?
Are you NOT pregnant and don't have certain other health conditions like an active infection or Parkinson's disease?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either the new Taperloc hip replacement with BioGuard coating or a standard hip replacement, as decided by the study doctors. After your surgery, you would need to attend regular follow-up appointments as requested by the study team. These appointments are important for the doctors to check your recovery, how well the hip replacement is working, and to make sure you are safe and comfortable. The study will involve observing your progress over a period of time, which will be explained to you in detail.

Potential risks and benefits

Participating in a study like this might offer the benefit of potentially receiving a new type of hip replacement design that could be very effective. However, as with any surgery, there are risks, such as infection, pain, or the need for further surgery. The new BioGuard coating is being studied for its safety, so there's always a small chance of unforeseen issues. You will be told about all the potential risks involved before you agree to take part. Remember, you have the right to withdraw from the study at any time, even if you've already agreed to participate, without affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

RJAH
Verified postcode
Oswestry, United Kingdom

Common questions

What is BioGuard coating?

It's a special layer on the new hip replacement parts that doctors are studying to see if it helps with safety and how well the hip works.

Why are they studying this new hip replacement?

Doctors want to find out if this new Taperloc hip replacement, which doesn't use cement, is safe and works well for people needing hip surgery due to arthritis.

Will I definitely get the new hip replacement?

You might get the new hip replacement with BioGuard, or you might get a standard one. The study is comparing both.

What is "cementless" hip replacement?

It means the new hip parts are designed to be held in place by your own bone growing onto them, rather than using special medical cement.

What if I change my mind about participating?

You can decide to stop being part of the study at any time, and it won't affect the care you receive from your doctors.