Active not recruitingNAINTERVENTIONAL

Nexus Evaluation Primary Trident II Uncemented Shell

Doctors are studying a new hip replacement component called the Trident® II. This part, a 'shell' for the hip socket, is already available in the UK, but we need more information on how well it works in the long term. This study will follow 125 patients in Edinburgh who receive this new component as part of their hip replacement. The main goal is to see how many of these hip components are still working well after 10 years. Researchers will also check how much the new hip helps patients with their daily activities and pain. This will help doctors understand if the Trident® II is a good choice for people needing hip replacement surgery.

At a glance

Status

Active not recruiting

Phase

Sponsor

NHS Lothian

Enrolment target

125

Start

01 Jun 2022

Estimated completion

25 Nov 2034

Arthritis of Hip Hip Dysplasia Hip Arthropathy Hip Osteoarthritis

What is this study about?

If you're facing hip replacement surgery due to conditions like arthritis or hip dysplasia, you might be interested in a study looking at a new part used in these operations. This study focuses on a specific component called the Trident® II, which is a new type of hip socket replacement. It's already approved for use and available to surgeons in the UK, but we don't have much information yet on how it performs over many years.

This research aims to change that. Doctors at the Royal Infirmary of Edinburgh are following 125 patients who receive the Trident® II as part of their total hip replacement surgery. They are particularly interested in finding out how long this new hip component lasts – specifically, whether it's still working well after 10 years. They will also be looking closely at how patients' pain and movement improve after their surgery.

By carefully observing these patients for a decade, the study hopes to provide valuable information to doctors and patients alike. It will help us understand the long-term success of the Trident® II hip component, ensuring that patients receive the best possible care for their hip problems.

Key takeaways

This study investigates a new hip replacement component called Trident® II.
It aims to see how long the Trident® II lasts and how well patients recover over 10 years.
Participation involves receiving the component during standard hip surgery and attending follow-up checks.
The study helps provide long-term data on this hip component, benefiting future patients.
It's conducted at the Royal Infirmary of Edinburgh and involves 125 patients.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be able to join this study, you would generally need to be between 18 and 75 years old and be planning to have your first total hip replacement surgery. The doctors need to make sure that the Trident® II hip component is suitable for you.

It's also important that you're willing and able to follow the study's instructions and attend follow-up appointments. You would also need to give your permission to be part of the study after understanding everything involved.

You wouldn't be able to join if your bones aren't strong enough to support the new hip part, or if you have a very high body mass index (over 40). Also, if your hip surgery is mainly to help with pain but you already have very limited movement, this study might not 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.

Are you between 18 and 75 years old?
Are you planning to have your first total hip replacement?
Is the Trident® II hip component suitable for your specific bone structure?
Can you commit to attending follow-up appointments for 10 years?
Is your Body Mass Index (BMI) 40 or below?
Are you able and willing to give your informed consent to participate?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the Trident® II hip component as part of your standard hip replacement surgery at the Royal Infirmary of Edinburgh. The surgery will be performed using a common technique. After your operation, you'll follow the usual care plan provided by the hospital.

You'll be asked to come back for follow-up appointments at specific times: after 1 year, 2 years, 5 years, 7 years, and finally at 10 years after your surgery. During these visits, doctors will check how your new hip is doing, how much you're able to move, and how you're feeling. There won't be any extra medications to take as part of this study. The total duration of your participation, including all follow-up appointments, will be 10 years.

Potential risks and benefits

Taking part in this study means you'll be contributing to valuable knowledge about a new hip replacement part, which could help future patients. For you, the surgical procedure and recovery will be similar to a standard hip replacement. All surgeries have some risks, but your doctors will discuss these with you as they would for any hip replacement. You will also have additional follow-up appointments over 10 years. Remember, joining a study is always your choice, and you are free to withdraw at any time without affecting your medical care.

Locations (1)

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

NHS Lothian
Verified postcode
Edinburgh, United Kingdom

Common questions

What is a 'hip replacement component'?

It's a manufactured part that replaces the worn-out or damaged sections of your hip joint during surgery.

What problems can this new hip part help with?

It's for people with conditions like arthritis or hip dysplasia that cause hip pain and limited movement.

Is the Trident® II hip component brand new or experimental?

No, it's already approved for use in the UK. This study is to gather more long-term information on how it performs.

Will my surgery be different if I join the study?

Your surgery will use standard techniques. The main difference is that you'll be followed closely for 10 years to see how the hip component lasts.

How long will I need to be in the study?

You will be followed for 10 years after your hip replacement surgery, with check-ups at specific times.