Active not recruitingOBSERVATIONAL

BC Study of G7 Cup and Compatible Femoral Stems

This study is checking how well a new hip replacement part, called the G7 Acetabular System, works. It's for people who need a new hip due to long-term joint problems like osteoarthritis (wear and tear arthritis), rheumatoid arthritis, or other conditions causing hip pain. Researchers will observe patients who receive this new implant to see how they recover and how the hip replacement performs over time. This helps ensure that new hip implants introduced in the UK are safe and effective for patients. It's part of a wider effort called 'Beyond Compliance' which involves manufacturers and surgeons working together to safely introduce new medical devices.

At a glance

Status

Active not recruiting

Sponsor

Zimmer Biomet

Enrolment target

230

Start

01 Nov 2015

Estimated completion

01 Dec 2030

Non-inflammatory Degenerative Joint Disease Osteoarthritis Avascular Necrosis Rheumatoid Arthritis

What is this study about?

This study is observing how well a new hip replacement component, specifically a part called the G7 Acetabular System, works for patients undergoing a hip replacement. The 'acetabular system' refers to the cup-shaped part of the hip replacement that fits into your pelvis.

The study focuses on people who need a hip replacement due to conditions like osteoarthritis, which is wear and tear of the joint, or rheumatoid arthritis, which is an inflammatory type of arthritis. It's also for those with avascular necrosis, where the bone tissue dies due to lack of blood supply, or other issues causing hip joint degeneration. The main goal is to check how safe and effective this new G7 hip cup is when used in real-world situations by surgeons.

This research is part of a very important UK initiative called 'Beyond Compliance'. This programme brings together the companies that make medical devices, the surgeons who use them, and a group of experts. Their aim is to make extra sure that any new medical device, like this hip replacement cup, is introduced safely and step-by-step into common use. By watching how patients do with this new implant, the study helps confirm its performance and safety, ultimately benefiting patients by ensuring high standards for new treatments.

Key takeaways

This study evaluates a new hip replacement cup called the G7 Acetabular System.
It's for people needing hip replacement due to common joint problems like arthritis.
The study is observational, meaning it tracks your progress during normal care.
It's part of a UK safety programme to ensure new implants are safe and effective.
Participation involves receiving the new implant as part of your surgery, with routine follow-up.
The aim is to monitor the implant's performance for up to 10 years.

Who may be eligible?

To join this study, you need to be at least 18 years old. You would be considered if you have joint problems like osteoarthritis, avascular necrosis, or rheumatoid arthritis that require a hip replacement on one side. You also need to be able to understand the study and agree to take part in writing.

There are several reasons why someone might not be able to join. For example, if you need a revision (redo) hip replacement, or if you need both hips replaced. Other reasons include certain other health problems like severe obesity (BMI over 40), some nerve or muscle conditions that affect the hip, or if you have a tumour or infection in the hip. Also, if there are significant problems with your bone structure, or if you've had an organ transplant, you might not be eligible.

Women who are pregnant, breastfeeding, or planning to become pregnant during the study period, and those not using an approved method of birth control, cannot take part. Additionally, if you have difficulty understanding English, have dementia or other serious mental health conditions, or if your life expectancy is less than five years, you won't be able to join.

Quick self-check

Are you 18 years old or older?
Do you need a hip replacement for a condition like osteoarthritis, rheumatoid arthritis, or avascular necrosis?
Are you able to speak and understand English well enough to give written consent?
Are you able to attend routine follow-up appointments and do you live in the UK?
Are you not pregnant, breastfeeding, or planning to become pregnant during the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will receive the G7 Acetabular System as part of your hip replacement surgery. This is an observational study, meaning that researchers will simply observe how you get on with the new implant under normal care. There aren't any extra study visits or assessments beyond what would usually be part of your standard medical care after a hip replacement. They will collect information about your recovery and how your hip replacement performs over time. The study aims to follow how the implant performs for up to 10 years, using information that's already gathered as part of your routine medical care.

Potential risks and benefits

The potential benefit of taking part is receiving a modern hip replacement component that is being carefully monitored as part of a national safety programme. Since this is an observational study of a device being used in standard care, there are no special risks beyond those typically associated with hip replacement surgery itself. You will always have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

The Royal Bournemouth Hospital
Bournemouth, United Kingdom

Common questions

What is an acetabular cup?

It's the cup-shaped part of a hip replacement that fits into your pelvis, replacing the worn-out socket of your hip joint.

What does 'Beyond Compliance' mean?

It's a UK initiative that ensures new medical devices like hip implants are introduced safely and carefully, with ongoing monitoring of their performance.

Will I get special treatment in this study?

No, you will receive standard medical care as you normally would after a hip replacement. The study just observes how you get on.

How long will the study follow me?

Data will be collected from your routine medical records for up to 10 years to see how the implant performs over time.

What are the main conditions this hip replacement is for?

It's for conditions like osteoarthritis, rheumatoid arthritis, and avascular necrosis that cause hip pain and require a hip replacement.