Active not recruitingOBSERVATIONAL

G7 BiSpherical Acetabular Shell PMCF Study

This study is checking how well a new hip replacement part, called the G7 BiSpherical Acetabular Shell, performs in real-world patients. It's designed to help people who need a total hip replacement due to conditions like arthritis or some types of fractures, by improving their hip function and reducing pain. Doctors will follow patients who receive this new implant to see how long it lasts, if there are any problems, and how much it helps with their pain and quality of life. The study involves several hospitals and will include a number of patients aged 18 or older who are able to understand and be part of the follow-up.

At a glance

Status

Active not recruiting

Sponsor

Zimmer Biomet

Enrolment target

160

Start

10 Dec 2017

Estimated completion

01 Dec 2031

Rheumatoid Arthritis Osteoarthritis Noninflammatory Degenerative Joint Disease Avascular Necrosis Correction of Functional Deformity Non-Union Fracture Femoral Neck Fractures Trochanteric Fractures

What is this study about?

You might be looking into this study because you or someone you know is considering a hip replacement. This particular study is all about a new part used in hip replacement surgery called the G7 BiSpherical Acetabular (say: Ah-set-a-byoo-lar) Shell. This shell is designed to be part of a total hip replacement, specifically to help people with painful hip conditions like different types of arthritis, or those who have had certain severe hip fractures that haven't healed well. The main aim of this new part is to hopefully give you a better-working hip and less pain.

The health industry regularly checks how new medical devices are working after they become available. This study is doing exactly that for the G7 BiSpherical Acetabular Shell. It's not testing a brand new, never-before-used device, but rather gathering more information on how well it performs in people who are already having it fitted as part of their hip replacement. Doctors will be carefully watching how long the implant lasts, if any unexpected problems occur, and how much it helps patients feel better and move more easily.

A few hospitals in the UK will be taking part in this study, with each hospital enrolling a certain number of patients. If you decide to join, it means doctors will collect information about your health, pain levels, and how your hip is doing using the new implant. This information is really important because it helps medical professionals understand the true benefits and safety of this hip replacement part for patients like you, helping to improve future care.

Key takeaways

The study checks how a hip replacement part (G7 BiSpherical Acetabular Shell) works.
It's for people having total hip replacements for various hip conditions.
Doctors will check how long the implant lasts and if it helps with pain and movement.
Patients need to be 18+ and willing to attend follow-up appointments.
You can stop taking part at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you generally need to be 18 years old or older and have reached full bone growth. You might be eligible if you're having a total hip replacement because of common hip problems like osteoarthritis, rheumatoid arthritis, or a condition where the bone isn't getting enough blood (avascular necrosis). People with certain unhealed hip fractures or issues needing correction might also be suitable. If you've had hip surgery in the past that didn't quite work, and now need a revision, you might also be considered.

It's very important that you're able to understand what the doctors tell you, follow their instructions, and are willing to come to all the follow-up appointments. You'll also need to sign a form saying you agree to take part in the study.

There are also some reasons why you might not be able to join. For example, if you have an infection, osteoporosis (weak bones), or certain other health conditions that could affect your bones or make the surgery risky. If you are pregnant or breastfeeding, you also won't be able to take part. The doctors will carefully check all these points to make sure the study is safe and right for you.

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 total hip replacement for conditions like arthritis or certain fractures?
Are you able to understand instructions and attend follow-up appointments?
Do you NOT have an active infection or severe osteoporosis?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it means you'll undergo a hip replacement surgery using the G7 BiSpherical Acetabular Shell. Before the surgery, you'll have a meeting where doctors explain everything about the procedure and the study, and you'll sign a consent form. After your surgery, doctors will regularly monitor your recovery and the performance of your new hip. This will involve appointments where they will ask you questions about your pain and how well you can move, you might fill out questionnaires about your quality of life, and you'll likely have X-rays to check the position and health of the implant. You'll need to commit to attending these follow-up appointments. The study is designed to follow patients over time, but the exact duration of your personal follow-up would be discussed with your doctor.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of receiving the G7 BiSpherical Acetabular Shell could be improved hip function and reduced pain, as well as contributing to medical knowledge that helps other patients. However, as with any surgery, there are risks involved, such as infection, bleeding, or the need for further surgery. These risks will be fully explained by your surgeon. You are entirely free to withdraw from the study at any time without it affecting your medical care.

Locations (5)

Cabinet du Dr. Miazzolo
Verified postcode
Perpignan, France
Orthopädische Chirurgie Müchen OCM
Verified postcode
Munich, Germany
Herzogin Elisabeth Hospital
Verified postcode
Braunschweig, Germany
Reinier de Graaf Groep
Verified postcode
Delft, Netherlands
Orthoprax AG
Verified postcode
Bern, Switzerland

Common questions

What is the G7 BiSpherical Acetabular Shell?

It's a specific part used in a total hip replacement to help improve movement and reduce pain in people with hip problems.

What kind of patients is this hip part for?

It's for people needing hip replacement due to conditions like arthritis, avascular necrosis, or certain types of hip fractures.

Is this a brand new, untested device?

No, it's already available for use, but this study is collecting more information on how well it performs in real patients after surgery.

What will I have to do if I join the study?

You'll have the hip replacement surgery and then attend regular follow-up appointments for check-ups, X-rays, and to answer questions about your hip and well-being.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating at any time, and it won't affect your medical care.