RecruitingNAINTERVENTIONAL

The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement

This research study, called The ACTIVE Trial, is comparing two types of hip replacement surgery for people with hip arthritis. One is a new approach called the H1 Implant, which is a 'hip resurfacing'. This procedure replaces the worn-out surfaces of the hip joint but keeps more of the patient's own bone. The other is the standard 'total hip replacement', where the entire hip joint is replaced. Doctors want to find out if the new hip resurfacing works as well as, or even better than, the standard replacement. They will look at how patients recover, their pain, how active they are, and any complications. This will help doctors understand the best options for people needing hip surgery in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Embody Orthopaedic Limited

Enrolment target

200

Start

21 Jul 2026

Estimated completion

31 Dec 2036

Osteoarthritis, Hip Inflammatory Arthritis

What is this study about?

Many people suffer from hip arthritis, which can cause significant pain and make everyday activities difficult. When other treatments don't help enough, hip replacement surgery can be a very effective solution. There are different types of hip replacement, and doctors are always looking for ways to improve these operations and offer the best options to patients.

This study, called The ACTIVE Trial, is focusing on a new type of hip replacement called the H1 Implant, which is a 'hip resurfacing'. Unlike a standard total hip replacement, where the top of your thigh bone (femoral head) is removed and replaced with an artificial one, hip resurfacing involves trimming and capping the bone with a smooth metal or ceramic surface, while keeping most of your own bone. The aim is to see if this newer approach works just as well as, or even better than, a standard total hip replacement, especially in terms of how active patients can be after surgery.

Patients taking part in this study will be randomly chosen to receive either the H1 Implant (hip resurfacing) or a standard total hip replacement. The doctors and researchers will then carefully follow their progress over time. They will compare how well patients recover, their pain levels, how active they are, and whether they experience any problems with either type of replacement. This comparison will help us understand which option might be best for different patients in the future.

Key takeaways

This study compares a new 'hip resurfacing' with standard 'total hip replacement'.
It aims to find out which surgery works best for hip arthritis patients.
Patients will be randomly assigned to one of the two surgery types.
The study will track recovery, activity levels, and any problems for up to 10 years.
Your participation could help improve future hip replacement treatments.

Who may be eligible?

To be considered for this study, you would need to be an adult who requires a first-time hip replacement for arthritis in one hip only. This arthritis could be due to general wear and tear (osteoarthritis) or other causes like injury, problems with blood supply to the bone, or inflammatory conditions.

There are also certain reasons why you might not be able to join. For example, if you have a very high Body Mass Index (BMI) of over 40, or if you have an active infection. You also wouldn't be eligible if your hip bone is too weak or damaged, or if you have severe bone thinning (osteoporosis). If you have other artificial joints in your leg, or expect to need more surgery on your leg soon, you might not be suitable either.

Finally, it's important that you are able to understand what the study involves and are willing to attend follow-up appointments for up to 10 years after your surgery. You must also be able to understand the language spoken where the operation takes place.

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.

Do you need a first-time hip replacement for arthritis in only one hip?
Is your BMI (Body Mass Index) 40 or less?
Do you have good bone quality in your hip and generally (not severe osteoporosis)?
Are you willing and able to attend follow-up appointments for up to 10 years?
Do you understand information given in English about the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a full assessment to ensure you are suitable. If you are, you would then be randomly assigned to receive either the new H1 hip resurfacing or a standard total hip replacement. Neither you nor your doctor would choose which operation you receive; it’s decided by chance, like flipping a coin.

After your surgery, you would have regular follow-up appointments. These appointments will involve checking how you are recovering, asking questions about your pain and activity levels, and possibly some scans or tests. We would also ask you to fill out questionnaires about how you feel and your physical activity. These check-ups will continue for up to 10 years after your operation, allowing us to see the long-term results of both types of hip replacement. You won't be given any experimental medication; the study is about comparing surgical procedures and their outcomes.

Potential risks and benefits

Taking part in this study could potentially benefit future patients by helping us understand which hip replacement option works best. For you personally, you would receive either a new hip resurfacing or a standard total hip replacement, both of which are established surgical procedures aimed at improving hip function and reducing pain. Like any surgery, both procedures carry risks, including infection, blood clots, nerve damage, or problems with the implant. The researchers will closely monitor for any complications related to your surgery or the implant. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

University Hospitals Dorset NHS Foundation Trust
Verified postcode
Bournemouth, United Kingdom· Recruiting
University Hospitals Coventry & Warwickshire
Verified postcode
Coventry, United Kingdom· Recruiting
Royal Cornwall Hospitals NHS Trust
Verified postcode
Truro, United Kingdom· Recruiting

Common questions

What is the main purpose of this study?

The study aims to compare a new type of hip replacement (hip resurfacing) with a standard total hip replacement, to see which works better for people with hip arthritis.

What's the difference between the two hip operations being studied?

A hip resurfacing (H1 Implant) replaces only the worn surfaces of your hip joint, keeping more of your own bone. A total hip replacement replaces the entire hip joint with artificial parts.

Will I get to choose which hip replacement I receive?

No, if you join the study, you will be randomly assigned to get either the new hip resurfacing or the standard total hip replacement. It's like drawing lots.

How long will I be followed up after my surgery?

You will be asked to attend follow-up appointments for up to 10 years after your hip replacement surgery.

What if I change my mind about participating?

You are completely free to withdraw from the study at any time, for any reason, and this will not affect your medical care.

How to find out more

Camilla Halewood, PhD

camilla.halewood@embody-ortho.com +442035764981 Official trial record

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