RecruitingNAINTERVENTIONAL

Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices.

This study is gathering real-world information about hip replacement implants and other devices used for fixing bone injuries, all made by FH Ortho. The main goal is to see how well these devices work and how safe they are for patients in their everyday lives. This type of study, called a Post-Market Clinical Follow-up, happens after a medical device has been approved for use in the UK and Europe. It helps manufacturers make sure their products continue to perform as expected and helps answer any specific questions about long-term safety or effectiveness. The study will collect details from both surgeons and patients to get a full picture of how these devices are doing for different types of hip surgery and injury repairs.

At a glance

Status

Recruiting

Phase

Sponsor

FH ORTHO

Enrolment target

800

Start

08 Jan 2024

Estimated completion

01 Dec 2038

Hip Surgery

What is this study about?

This study is designed to keep a close eye on certain hip implants and other devices made by FH Ortho, a company that makes medical equipment. When medical devices are first approved for use in the UK and Europe, they've gone through rigorous testing. However, studies like this one, called a Post-Market Clinical Follow-up (PMCF), are essential to gather more information once the devices are being used by many people in real-life situations.

The main aim is to understand how well these hip implants perform over time and to confirm their safety. This includes devices used for hip replacement surgery and those used to fix broken bones around the hip. By collecting information from a variety of patients and different surgeons, the study hopes to get a comprehensive view of how these devices work in various scenarios and combinations.

To make it easy for doctors and patients to share information, the study uses modern tools. Surgeons will complete electronic forms, and patients can share their experiences using their phones, tablets, or computers. This 'dynamic' approach means that as patients complete the study, new patients can be included, ensuring a continuous flow of valuable data.

Key takeaways

The study watches how FH Ortho hip devices perform after surgery.
It helps ensure the long-term safety and effectiveness of these implants.
Information is collected from both surgeons and patients using digital tools.
You won't receive new treatments; it's an observation of existing care.
Participation helps improve hip surgery for future patients.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, who is having or has already had hip surgery using an FH Ortho device. This could be for a hip replacement or to fix a bone injury. It's important that the device was used exactly as recommended by the manufacturer and that your surgery took place at one of the hospitals taking part in this study. You'll also need to agree to participate after getting all the information about the study, and you might be asked to sign a consent form.

There are several reasons why someone might not be able to join. For example, if you have an active infection or a long-lasting infection, or if you have certain mental or nerve conditions that could affect how well the implant works. Also, if your bones aren't strong enough, or if you have allergies to materials in the implant, you wouldn't be able to take part. Conditions like certain metabolic diseases (which affect how your body works) or taking medications that might stop your bones from healing properly would also mean you can't join.

Finally, if you depend on certain drugs, or if you are unable to follow medical advice, or if you are a 'protected adult' (meaning someone who needs special legal protection for their decisions, often due to a severe learning disability), you would not be eligible. In some countries like France, you also need to be covered by social insurance.

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 18 years old or older?
Did you have hip surgery (replacement or injury repair) using an FH Ortho device?
Was your surgery performed at a hospital taking part in this study?
Do you not have an active infection or certain nerve/mental conditions?
Are you able to follow medical advice?
Are you not allergic to any materials in the implant?

Answer every question to see your result.

What does participation involve?

Taking part in this study primarily involves allowing the researchers to collect information about your hip implant and your recovery journey. You won't need to take any new medications as part of the study; it's all about observing how the existing FH Ortho devices perform. Surgeons will provide details about your surgery and the device used, and you, as the patient, will be asked to regularly share your experiences and how you're feeling after your surgery.

This information will typically be collected using easy-to-use electronic forms. You might fill out questionnaires on your phone, tablet, or computer from the comfort of your home. The frequency and type of assessments will be explained to you in detail before you agree to join. The total duration of your participation will depend on the study's plan for monitoring the device, but it will involve follow-up over a period of time to track how you're doing with your new hip device.

Potential risks and benefits

The main benefit of taking part in this study is contributing to better understanding the safety and performance of hip implants, which can help improve future treatments for everyone. As this is an observational study, focusing on devices already approved and used in standard care, there are no new medical procedures or treatments involved, meaning no additional direct medical risks beyond those typically associated with hip surgery itself. However, sharing your personal health information is part of the study, and while precautions are in place to protect your privacy, there's always a minimal risk of data breaches. You have the full right to withdraw from the study at any time, without giving a reason, and this will not affect your medical care.

Locations (5)

Clinique Pasteur
Verified postcode
Guilherand-Granges, France· Recruiting
Centre Hospitalier Du Haut Bugey
Verified postcode
Oyonnax, France· Recruiting
Polyclinique Reims-Courlancy
Verified postcode
Reims, France· Recruiting
Clinique Mutualiste La Sagesse
Verified postcode
Rennes, France· Recruiting
Clinique de l'Atlantique
Verified postcode
Saint-Herblain, France· Recruiting

Common questions

What kind of hip surgery is this study about?

This study is gathering information about hip replacement surgery and operations to fix bone injuries around the hip, all using FH Ortho medical devices.

Do I have to take any new medicines if I join?

No, you don't have to take any new medicines. This study is just about observing how the FH Ortho devices work when used in standard care.

How will my information be collected?

Your doctors will fill out electronic forms, and you might be asked to share your experiences using a phone, tablet, or computer.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without giving a reason, and it won't affect your medical care.

What's a Post-Market Clinical Follow-up study?

It's a study done after a medical device has been approved for use, to keep checking its safety and how well it performs in real-life situations.

How to find out more

Vincent GAUDIOT, MD

vincent.gaudiot@wanadoo.fr +33 2 40 95 92 81 Official trial record

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