Active not recruitingOBSERVATIONAL

Multicentre Prospective Study to Evaluate Long-term Clinical Outcomes of the Sirius Cemented Femoral Stem

This study is investigating a specific type of hip replacement component called the Sirius cemented femoral stem. Researchers want to see how well patients recover and how long the new hip lasts, checking its performance at various points up to 10 years after surgery. They will look at how much pain is reduced, how well people can move, and the overall safety of the implant. The study aims to gather important information for both patients and doctors about the long-term success of this hip replacement. It includes people needing hip replacements for conditions like arthritis, avascular necrosis, or severe fractures, provided they meet certain health criteria.

At a glance

Status

Active not recruiting

Sponsor

Zimmer Biomet

Enrolment target

250

Start

01 Mar 2013

Estimated completion

01 Mar 2025

Arthroplasty, Replacement, Hip

What is this study about?

This research study is focused on a particular part of a hip replacement operation, specifically a component called the Sirius cemented femoral stem. A hip replacement involves replacing a damaged hip joint with an artificial one. The femoral stem is the part of the new hip that fits into your thigh bone (femur).

The main goal of this study is to understand how well this specific hip replacement component works in patients over a long period. Researchers will be observing participants for up to 10 years after their hip replacement surgery. They want to see how much improvement people experience in their daily activities, how stable the new hip feels, and if there are any safety concerns. This information helps doctors understand which hip replacements are most effective and durable.

By carefully watching how people get on with this hip stem, the study aims to provide valuable insights into its long-term performance. This helps ensure that patients receive the best possible care and that hip replacements continue to improve for people affected by conditions like arthritis or fractures needing this kind of surgery.

Key takeaways

Researches look at how well a hip replacement part (Sirius stem) works long-term.
Follow-up checks happen at several points, up to 10 years after surgery.
This study is for people needing a hip replacement due to arthritis, fractures, or similar issues.
It aims to improve understanding of hip replacement safety and effectiveness.
You can stop participating at any time without compromising your medical care.

Who may be eligible?

To be considered for this study, you would generally be someone who needs a hip replacement because of conditions like arthritis (where joints wear down), avascular necrosis (where part of the bone tissue dies), or certain severe hip fractures. It also includes people who might need a new hip replacement because a previous one didn't work as expected.

However, there are also reasons why you might not be able to join. For example, if you have an infection in your body, especially near your bones, or if you have severe bone-thinning (osteoporosis) or other bone conditions that might affect how the implant heals. People who find it difficult to follow instructions due to certain conditions or those with severe muscle weakness or nerve issues might also be excluded. The study is open to both men and women, aged 18 and over.

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.

Do you need a hip replacement for conditions like arthritis or a severe fracture?
Are you generally healthy enough for surgery, without active infections?
Do you not have severe bone thinning (osteoporosis) or similar bone conditions?
Are you able to attend follow-up appointments over several years?
Are you 18 years old or over?

Answer every question to see your result.

What does participation involve?

This study will involve ongoing check-ups after your hip replacement surgery. You would have your recovery and hip function monitored at specific times: at 3 months, 1 year, 3 years, 5 years, 7 years, and finally at 10 years after your operation. These check-ups will assess how well your new hip is working, your comfort levels, and could include X-rays to see the implant's position and stability. The total duration of your participation would be up to 10 years.

Potential risks and benefits

Taking part in any study involves weighing potential benefits and risks. The main benefit here is contributing to our understanding of hip replacements, which could improve future care for patients. You would also receive regular medical follow-ups, which might offer some reassurance. As with any surgery, there are general risks associated with hip replacement, and specific risks linked to the implant itself will be discussed with you by your medical team. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Sygehus Vejle
Verified postcode
Vejle, Denmark
University Hospital of Wales, Llandough Hospital
Verified postcode
Penarth, United Kingdom

Common questions

What is the Sirius cemented femoral stem?

It's a specific component, or part, of an artificial hip joint that is placed into your thigh bone during hip replacement surgery. 'Cemented' means it's fixed in place with bone cement.

Why is this study important?

It helps doctors understand how well this specific hip replacement part works over many years, looking at safety and how much it helps people move. This information can improve future hip replacement care.

Will I get a different type of hip replacement if I join?

This study focuses on people who are already having a hip replacement using the Sirius cemented femoral stem. It's not about trying a completely new or experimental type of surgery.

What will happen during the check-ups?

The check-ups will assess your hip's function, discuss your comfort, and might include X-rays to monitor the implant. They are part of the long-term follow-up.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any point, and this will not affect your medical care.