Active not recruitingOBSERVATIONAL

Plasmafit® Revision Structan® Hip Endoprosthesis Cup

This study is an observational study looking at a new type of hip replacement cup called the Plasmafit Revision Structan Hip Endoprosthesis. It's designed for people who need a new hip, either for the first time or as a replacement for an old hip implant. Researchers want to see how well this new cup performs in real-world patients during their everyday clinical care. They will be collecting information on patients' progress both through medical checks and X-rays. The main goal is to understand how effective and safe this new hip cup is for a wide range of patients.

At a glance

Status

Active not recruiting

Sponsor

Aesculap AG

Enrolment target

Start

12 Apr 2021

Estimated completion

01 Jun 2027

Osteolysis Arthroplasty Complications Instability of Prosthetic Joint Degenerative Osteoarthritis Rheumatic Arthritis Fractures, Hip Femoral Head Avascular Necrosis Prosthesis Failure

What is this study about?

This study is about a new part for hip replacements. It's called the Plasmafit Revision Structan Hip Endoprosthesis Cup. When you have a hip replacement, the main goal is to fix problems like severe arthritis (wear and tear of the joint), injuries, or if a previous hip replacement isn't working well.

The researchers want to see how this specific new hip cup works in people who are having a hip replacement operation. It's not a study where people get different treatments. Instead, doctors will decide to use this new cup if they think it's the best option for their patient. The study will then follow these patients to see how they get on with their new hip and collect information from their regular check-ups and X-rays.

This kind of study, called an 'observational study,' is important because it helps doctors understand how new medical devices perform in everyday medical practice. By collecting information from many patients, they can learn if the new cup is helping people move better, reducing pain, and overall improving their quality of life after a hip replacement.

Key takeaways

This study observes a new hip replacement cup (Plasmafit Revision Structan).
It aims to see how well the new cup works in regular patient care.
Participation means your doctor chose this cup for your hip surgery.
Information is gathered from your routine check-ups and X-rays.
It's for adults 18+ needing a hip replacement.
You can withdraw at any time without affecting your medical care.

Who may be eligible?

This study is for adults who are 18 years or older and need a hip replacement. Your doctor would specifically need to decide that this new Plasmafit Revision Structan hip cup is the right choice for your operation. This might be for a first-time hip replacement or if you're having surgery to fix an older hip replacement that isn't working properly.

Before you can join, you'd need to understand the study and agree to take part by signing a consent form. It's also important that your bone is in a suitable condition for this specific type of hip cup to be fitted securely.

However, you wouldn't be able to join if you are under 18, pregnant, or if you have an infection in your hip area. Also, if there are reasons that would make it difficult for you to come to follow-up appointments, such as physical or mental health challenges, you might not be able to participate.

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?
Do you need a hip replacement for conditions like arthritis or a previous implant problem?
Has your doctor discussed using the Plasmafit Revision Structan hip cup for you?
Are you able to attend follow-up appointments after surgery?
Are you currently not pregnant?
Do you have a hip infection?

Answer every question to see your result.

What does participation involve?

If you join this study, it means that your doctor has chosen to use the Plasmafit Revision Structan hip cup during your hip replacement surgery. You wouldn't need to do anything extra before or during the operation that you wouldn't normally do. The study simply involves your doctors collecting information from your routine hospital visits and check-ups after your surgery. This includes details from your medical notes and any X-rays you might have. You would continue to follow your surgeon's advice for recovery and rehabilitation. There isn't a set end date for your participation; follow-up information would be collected as part of your ongoing care.

Potential risks and benefits

The main benefit of participating is that you would receive a new, modern hip cup as part of your standard care, which your surgeon believes is the best option for you. This study doesn't involve any extra procedures, so the risks are generally the same as for any standard hip replacement surgery, such as infection, blood clots, or dislocation of the hip. You are always free to change your mind and withdraw from the study at any time without it affecting your medical care.

Locations (4)

Orthopädische Klinik König-Ludwig-Haus
Verified postcode
Würzburg, Germany
Herzogin Elisabeth Hospital
Verified postcode
Braunschweig, Germany
Gemeinschaftskrankenhaus Bonn
Verified postcode
Bonn, Germany
Universitätsklinikum des Saarlandes
Verified postcode
Homburg, Germany

Common questions

What is osteolysis?

Osteolysis is when bone tissue breaks down, often around a hip replacement, which can loosen the implant.

What does 'observational study' mean?

It means doctors observe patients receiving a treatment as part of their normal care, without changing how care is given for the study. They just collect information.

Is this a new type of hip replacement?

Yes, this study is looking at a specific, newer hip replacement cup called Plasmafit Revision Structan.

Do I have to do anything differently if I join?

No, you would simply receive the new hip cup as part of your planned surgery. The study just collects information from your routine care.

Who is funding this study?

The information provided does not specify the funding source for this study, but a common practice is that medical device companies fund studies evaluating their products.