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The Medacta International SMS Post-Marketing Surveillance Study

This important UK study is designed to keep track of how a specific hip replacement part, called the SMS femoral stem, performs after it's been used in patients. It's for adults aged 18 to 75 who are having a full hip replacement because of severe hip pain caused by conditions like various types of arthritis or other hip problems. The main goal is to follow these patients over a long period to see if the new hip replacement part works well and helps improve their quality of life. This type of study ensures medical devices are safe and effective for people in the real world, after they have already been approved for use.

At a glance

Status
Recruiting
Sponsor
Medacta International SA
Enrolment target
550
Start
01 Jul 2015
Estimated completion
01 Jul 2032

What is this study about?

This study is about a particular part used in hip replacement surgery, called the SMS femoral stem. When you have a hip replacement, the surgeon removes your damaged hip joint and replaces it with artificial parts. The femoral stem is the part that fits into your thigh bone (femur).

The main purpose of this study is to watch how this specific SMS femoral stem works in people after they have had their hip replacement. It's like checking in with patients to see if the new hip joint is doing its job well over a long period. This is really important because it helps doctors and manufacturers understand if the hip replacement part is safe and effective for patients in their everyday lives. It helps gather real-world information that isn't always clear from studies done before a product is put on the market.

By carefully checking how the SMS femoral stem performs, researchers can make sure that patients are getting the best possible care and that hip replacements continue to improve for people with painful hip conditions. The information collected from studies like this helps healthcare professionals make informed decisions about the best treatments for their patients.

Key takeaways

  • This study tracks a specific hip replacement part (SMS femoral stem) after surgery.
  • It helps ensure the hip replacement part works well and is safe for patients.
  • Participation involves sharing information from your regular hip replacement check-ups.
  • It lasts for 10 years, following your progress over time.
  • You won't have extra treatments or medications due to the study.
  • You can stop participating at any time without affecting your medical care.

Who may be eligible?

This study is looking for adults between 18 and 75 years old who are scheduled to have their first full hip replacement surgery. You would be considered if you have severe and ongoing hip pain that is making it difficult to live your life, especially if this pain is caused by conditions such as various forms of arthritis (like osteoarthritis or traumatic arthritis) or other problems affecting the hip such as a condition where the hip joint doesn't form correctly from birth, or a problem where the bone in your hip joint isn't getting enough blood.

However, there are some reasons why you might not be able to join. For example, if you currently have an infection, are pregnant, or have certain mental health conditions that might make it hard to understand or complete the study requirements. Also, if your hip bones are very unusually shaped, or if you have certain bone conditions like severe thinning of the bones (osteoporosis) or soft bones (osteomalacia), or if you are allergic to the materials used in the hip replacement.

Additionally, you wouldn't be able to join if you have active rheumatoid arthritis, certain muscle or nerve diseases, or other health problems that might prevent you from getting back to walking independently after surgery. You also need to be able and willing to give your permission to be part of the study.

Quick self-check
  • Are you between 18 and 75 years old?
  • Are you having your first total hip replacement?
  • Do you have severe hip pain from arthritis or similar hip conditions?
  • Do you *not* currently have an infection or are you not pregnant?
  • Are you able to agree to be part of the study?
  • Are you able to attend follow-up appointments for up to 10 years?

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

What does participation involve?

If you decide to take part in this study, you won't need to do anything extra beyond your standard medical care for your hip replacement. The study involves collecting information about your progress and the performance of your SMS femoral stem during your regular follow-up appointments with your surgeon. You won't be given any new medications or treatments specifically for the study. The study period will involve attending appointments over a period of 10 years to allow researchers to see the long-term effects of the hip replacement. You will continue to see your own doctor or surgeon for your usual care.

Potential risks and benefits

The main benefit of taking part in this study is helping gather important information about the long-term performance of this hip replacement component, which can ultimately benefit future patients. There are no additional direct medical benefits to you beyond the relief and improved mobility you would expect from a successful hip replacement surgery. Since this study primarily involves observation during your routine care, there are no extra medical risks associated with taking part. You have the full right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (4)

  • Herz-Jesu Krankenhaus
    Vienna, Austria· Recruiting
  • Istituto Ortopedico Galezzi
    Milan, Italy· Recruiting
  • Bürgerspital Solothurn
    Solothurn, Switzerland· Recruiting
  • The Elective Orthopaedic Centre (EOC)
    Epsom, United Kingdom· Recruiting

Common questions

What is the SMS femoral stem?

It's a specific part of a hip replacement that fits into your thigh bone (femur).

Do I need to take any special medication for this study?

No, you don't need to take any special medications or have extra treatments just for the study.

How long does the study last?

The study aims to follow you for up to 10 years during your regular check-ups.

Who is running this study?

The study is being run by Medacta International, the company that makes the SMS femoral stem, for important safety and performance checks.

What if I change my mind about being in the study?

You can leave the study at any time without it affecting your medical care.

How to find out more

Mara Colombo, Eng

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

Interested in taking part?

Register your interest

Share your details and the research team for "The Medacta International SMS Post-Marketing Surveillance St…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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