Active not recruitingOBSERVATIONAL

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

This is a follow-up study for people who have had hip revision surgery using a specific type of hip implant called the PROFEMUR® L Revision Femoral Stem. The company that makes this implant, MicroPort Orthopedics, is checking to see how safe and effective it is over time. Many health authorities require these kinds of studies for hip implants that are new to the market, to gather real-world information on how they perform. This helps confirm the implant is working as expected and continues to be a safe choice for patients. Taking part would involve letting the study team collect information from your regular check-ups.

At a glance

Status

Active not recruiting

Sponsor

MicroPort Orthopedics Inc.

Enrolment target

Start

04 Sep 2015

Estimated completion

01 Oct 2027

Joint Disease

What is this study about?

Imagine you've had a hip replacement, and for some reason, that old implant needs to be replaced with a new one. This second operation is called a 'revision hip replacement'. This study is specifically looking at a new part used in these revision surgeries, called the PROFEMUR® L Revision Femoral Stem. It's an important part of the hip joint that goes into your thigh bone.

The health authorities that approve medical devices, like the ones in the UK, want to make sure that new implants are not only safe when they first come out, but also that they continue to work well and stay safe for many years. This study is a way to keep an eye on how this particular implant performs in people who have received it. It helps gather real-world information after the implant has been approved and is being used in patients.

The main goal is to carefully check the safety of the PROFEMUR® L Revision Femoral Stem and how well it helps patients. This information is really valuable because it helps doctors and patients make informed decisions about treatment options and ensures that hip implants continue to meet high standards for patient care.

Key takeaways

This study tracks the safety and performance of a specific hip implant.
It's for people who've had a revision hip replacement with the PROFEMUR® L Revision Femoral Stem.
Your participation helps improve knowledge about hip implants.
You won't have extra appointments or take new medications.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you would need to have already had an operation to replace an old hip implant with a new one, and specifically have received the PROFEMUR® L Revision Femoral Stem as part of that surgery. You'll also need to be willing and able to attend your usual follow-up appointments and let the study team collect information from these visits.

There are also some reasons why you wouldn't be able to join. For example, if you are already taking part in another medical study or if you are unable or unwilling to sign a consent form that explains everything about the study. People with certain issues like substance abuse or those who are in prison, or facing prison, would also not be able to take part.

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.

Have I had a hip revision surgery?
Was the PROFEMUR® L Revision Femoral Stem used in my surgery?
Am I able and willing to attend my normal follow-up appointments?
Am I not currently involved in another medical study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, it generally means allowing the study team to collect information from your routine follow-up appointments after your hip revision surgery. You won't have any extra visits just for the study. They'll look at how you're doing, check the implant, and record any information about your progress. There are no special medications to take or treatments to receive as part of this study. The total duration of your participation would be for the length of your normal follow-up schedule for your hip implant, which could be several years.

Potential risks and benefits

The main benefit of taking part is that your involvement helps gather important information about the long-term safety and effectiveness of this hip implant. This helps future patients and improves overall medical knowledge. There are very few direct risks to you, as you will be having your regular check-ups anyway. The study mostly involves collecting information from these routine appointments. You will not receive any experimental treatments. You are always free to change your mind and withdraw from the study 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.

Royal Cornwall Hospital
Verified postcode
Truro, United Kingdom

Common questions

What is a 'revision' hip replacement?

It's an operation to remove and replace an old hip implant that has worn out or has developed a problem.

What is the PROFEMUR® L Revision Femoral Stem?

It's a specific part of a hip implant that doctors use during a revision hip replacement, which goes into your thigh bone.

Do I have to take any new medicines for this study?

No, you don't need to take any special medicines or have any extra treatments for this study.

Will I have extra doctor's appointments?

No, you only need to attend your usual, routine follow-up appointments for your hip replacement.

Can I leave the study if I change my mind?

Yes, you can choose to stop being part of the study at any time, and it won't affect your medical care.