Active not recruitingOBSERVATIONAL

H1 Hip Resurfacing Arthroplasty

This study is investigating a new ceramic hip resurfacing operation called H1 Hip Resurfacing. It's for individuals aged 18-70 who suffer from hip pain due to conditions like hip arthritis or bone problems. The main goal is to check if this new ceramic hip is as safe as, or safer than, existing metal-on-metal hip resurfacing methods, particularly in preventing the release of metal particles into the body. Researchers will follow patients for 10 years after their surgery to see how well the new hip works, how comfortable they are, and if there are any problems. This will help understand if the H1 hip resurfacing is a good option for people needing hip surgery.

At a glance

Status

Active not recruiting

Sponsor

Embody Orthopaedic Limited

Enrolment target

250

Start

26 Sep 2017

Estimated completion

25 Mar 2033

Hip Osteoarthritis Hip Necrosis Hip Dysplasia

What is this study about?

You've been invited to learn about a study that's looking into a new type of hip replacement called H1 Hip Resurfacing. This operation is designed for people who have ongoing hip pain due to conditions like hip arthritis (osteoarthritis), problems with blood supply to the hip bone (necrosis), or issues with how the hip joint developed (dysplasia).

The main idea behind this study is to see how well this new ceramic hip replacement works. Importantly, it's comparing a ceramic hip, which doesn't use any metal-on-metal parts, to older metal-on-metal hip replacements. Doctors want to know if the H1 ceramic hip is just as safe, or even safer, especially when it comes to avoiding the release of tiny metal particles that have been a concern with some older metal hip replacements.

Over the next 10 years, the medical team will keep a close eye on people who have this H1 ceramic hip. They'll be checking things like how comfortable you are, how well you can move, and if the new hip continues to work properly. This long follow-up will help them understand the full benefits and any potential problems over time, and ultimately help more people with hip pain in the future.

Key takeaways

This study evaluates a new ceramic hip resurfacing designed to avoid metal-on-metal contact.
It aims to confirm the safety and effectiveness of the H1 ceramic hip.
Patients will be followed for 10 years to track long-term results.
The study compares the new ceramic hip to older metal hip replacements.
It's for people aged 18-70 with certain hip conditions needing surgery.
Your general hip health and bone quality are important for eligibility.

Who may be eligible?

To join this study, you would typically be between 18 and 70 years old and need a hip replacement because of conditions like arthritis, poor bone blood supply, or hip development problems. It's important that you have enough healthy bone in your hip for this specific type of resurfacing surgery.

You also need to be able to understand the study information and agree to come for regular check-ups for up to 10 years after your surgery. Being able to understand the local language where the study is taking place is also key.

There are certain reasons you might not be able to join. For example, if you are very overweight (BMI over 40), have an active infection, certain bone conditions like severe osteoporosis, or inflammatory joint problems. If you've recently had other joint surgeries or are taking certain medications that affect your bones, you might also not be suitable. The team will carefully check all these details with you.

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.

Am I between 18 and 70 years old?
Do I need a hip replacement for conditions like arthritis or bone problems?
Do I have enough healthy bone in my hip for resurfacing surgery?
Am I willing and able to attend regular check-ups for 10 years?
Do I have other serious health problems like active infections or severe osteoporosis?
Is my BMI (body mass index) 40 or less?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll undergo the H1 Hip Resurfacing operation. After the surgery, you'll have regular check-ups with the medical team for up to 10 years. These appointments will involve various assessments, including looking at how well your hip is working, your pain levels, and your general comfort. They will also perform blood tests to check for any issues and take X-rays to see how the hip implant is sitting within your bone. You won't be given any new or special medications as part of this study, but your existing medications will be reviewed. The total duration of your involvement will be around 10 years to allow researchers to gather long-term information on the new hip replacement.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new ceramic hip resurfacing device which aims to avoid some of the concerns associated with metal-on-metal implants. This could lead to improved hip function and pain relief. Like any surgery, there are potential risks, including those associated with hip surgery itself, such as infection, blood clots, or the need for further surgery. While the ceramic material is designed to be safe, there's always a chance of unexpected issues, although the study is carefully designed to monitor these. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (2)

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

Charing Cross Hospital
Verified postcode
London, United Kingdom
Kind Edward VII's Hospital
Verified postcode
London, United Kingdom

Common questions

What is 'hip resurfacing'?

Hip resurfacing is a type of hip replacement where only the damaged surfaces of your hip joint are replaced, rather than removing the entire top of your thigh bone.

Why 10 years of follow-up?

Following patients for 10 years helps doctors understand how well the new hip works over a long period, which is important for confirming its safety and effectiveness.

What does 'non-metal-on-metal' mean?

It means the parts of the hip replacement that rub together when you move are made of ceramic, not metal. This avoids concerns about metal particles that can be released from older metal hip replacements.

Will I get paid to be in the study?

Generally, study participants are not paid, though some studies may cover travel expenses for appointments. This will be explained in detail if you are invited to participate.

Is this a brand new type of surgery?

Hip resurfacing is an established procedure, but this study is looking at a new specific design of the ceramic H1 hip resurfacing implant to confirm its safety and effectiveness.