RecruitingOBSERVATIONAL

Multicentre SMS Study - FR

This study is designed to see how well a particular type of artificial hip, called the SMS femoral stem, performs when used in total hip replacement surgery. It's for people experiencing severe hip pain and difficulty due to conditions like osteoarthritis, hip dysplasia, or a problem where the bone in the hip joint doesn't get enough blood (avascular necrosis). Doctors will observe how stable and effective this hip replacement is over time in patients who receive it. The study aims to gather important information about this implant in a real-world setting to help improve future care, and it focuses on adults aged 18 to 75. It's not comparing it to other treatments, but rather carefully tracking outcomes for those who get this specific implant.

At a glance

Status

Recruiting

Sponsor

Medacta International SA

Enrolment target

260

Start

01 Sep 2024

Estimated completion

01 Sep 2037

Dysplasia of Hip Joint Hip Osteoarthritis Traumatic Arthritis of Hip Avascular Necrosis of Femur Head

What is this study about?

This study, called the "Multicentre SMS Study," is looking into a specific type of artificial hip joint component used in hip replacement surgery. This component is known as the SMS femoral stem. Hip replacement surgery, also called Total Hip Arthroplasty, is a common operation for people who have severe hip pain and trouble moving because of conditions like arthritis, hip dysplasia (where the hip joint didn't form properly), or avascular necrosis (where the bone tissue in the hip dies due to a lack of blood supply).

The main goal of this study is to observe how well the SMS femoral stem works after it's been put into a patient. Doctors want to understand its "performance" – meaning how stable it is and how well patients can move and use their new hip – over time. It's a watchful study, meaning they're not trying out new medical ideas or comparing this hip replacement to another type; instead, they are carefully collecting information on how it performs in everyday use among many different patients in several hospitals.

By collecting this information, doctors and manufacturers can learn more about the long-term success and stability of this particular hip replacement. This helps ensure that patients receive the best possible care and that the implants used are well-understood and effective. The study is very important for improving how hip replacements are done and ensuring their reliability for people needing this life-changing surgery.

Key takeaways

The study looks at how well a specific hip replacement works.
It's for people needing a total hip replacement due to severe hip pain.
Participation means having the SMS femoral stem and attending follow-up checks.
It's not comparing treatments, but observing the implant's performance.
You can withdraw from the study at any time.
The study helps doctors understand and improve hip replacement surgery.

Who may be eligible?

To join this study,您 must be between 18 and 75 years old and need a complete hip replacement because of severe pain or disability from conditions like osteoarthritis, traumatic arthritis, hip dysplasia, or avascular necrosis of the hip bone. You must also be scheduled to receive the specific SMS femoral stem for your hip replacement and be willing to follow all the study's rules.

However, there are certain situations where you would not be able to take part. For example, if you are pregnant or breastfeeding, already involved in another medical study, or have certain health conditions like active rheumatoid arthritis, severe bone weakening (osteomalacia), or an infection. If you have very unusual hip anatomy, severe muscle problems, or an allergy to the implant materials, you would also not be able to join. Additionally, you cannot participate if you are unable to understand and agree to the study, or if other health issues would make it unlikely for you to regain independent movement after the surgery.

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 between 18 and 75 years old?
Do you need a total hip replacement for conditions like arthritis or hip dysplasia?
Is your surgeon planning to use the Medacta SMS femoral stem?
Are you able to attend follow-up appointments?
Are you free from severe underlying health conditions like active infections or certain bone diseases?
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, the main intervention you'll receive is the total hip replacement surgery using the SMS femoral stem, as planned by your surgeon for your condition. The study itself is about observing and collecting information about this hip replacement. This means that after your surgery, the research team will regularly check in with you to see how your new hip is performing. This will likely involve follow-up appointments where they might ask you questions about your pain, how well you can move, and your general well-being. They might also take X-rays or other scans to check the position and stability of the implant. You'll need to attend all scheduled follow-up visits as requested by the study team. The total duration of your participation will depend on the study's observation period, which your doctor will explain fully.

Potential risks and benefits

Participating in this study means your hip replacement operation will use a specific implant (the SMS femoral stem). The potential benefits are that your medical team will closely monitor your recovery and the performance of your hip replacement, which could lead to very thorough follow-up care. However, hip replacement surgery, like any major operation, carries risks such as infection, blood clots, or the need for further surgery in the future, regardless of the study. The specific risks associated with the SMS femoral stem will be fully explained by your surgeon. You have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (1)

Clinique de l'Union
Verified postcode
Saint-Jean, France· Recruiting

Common questions

What is the SMS femoral stem?

It's a specific type of artificial part used in hip replacement surgery that goes into your thigh bone.

Why is this study being done?

Doctors want to understand how well this particular hip replacement works in people who receive it, checking its stability and performance over time.

Do I have to do anything differently for this study?

You'll have your hip replacement as planned, but you'll need to attend all scheduled follow-up appointments so the doctors can monitor your new hip.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, and this will not affect your medical care.

Who is paying for this study?

The information provided does not specify who is funding the study. You should ask the study team for this detail.

How to find out more

Paul Maisongrosse

paul.maisongrosse@hotmail.fr 0033 05 61 37 85 93 Official trial record

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