Active not recruitingNAINTERVENTIONAL

Cemented TrendHip® - Multicenter PMCF Study on Total Indications

This study is looking at a type of hip replacement part called the TrendHip® stem. Doctors use this part in hip replacement surgery to help people with hip pain from conditions like arthritis or injuries. The study wants to see how well this hip replacement works and if it's safe for patients in real-world use. It will follow people who have had this hip replacement to check their progress and how they are feeling after the operation. This helps doctors and manufacturers understand if the product is performing as expected and continues to be a good option for patients needing hip replacements.

At a glance

Status

Active not recruiting

Phase

Sponsor

Aesculap AG

Enrolment target

119

Start

12 Oct 2021

Estimated completion

08 May 2028

Coxarthrosis; Primary Coxarthrosis; Post-Traumatic Necrosis, Femur Head Rheumatoid Arthritis Fractures, Hip Hip Dysplasia

What is this study about?

Imagine you've been having a lot of hip pain, perhaps because of arthritis, an injury, or another hip problem. Your doctor might suggest a hip replacement operation to help you feel better and move more easily. During this surgery, parts of your hip joint are replaced with artificial ones. One of these artificial parts is called a femoral stem, which fits into your thigh bone.

This particular study is focusing on a specific type of femoral stem called the cemented TrendHip®. It's already approved for use, and this study isn't testing a brand-new, unproven treatment. Instead, it's a follow-up study to see how well patients are doing after receiving this hip replacement in their everyday lives. It's like checking in with people to make sure the hip replacement is working as expected and safely over time.

The main goal is to understand the performance and safety of the cemented TrendHip® stem. By gathering information from people who've had this hip replacement, the researchers can learn if it continues to be a good and reliable choice for patients like you.

Key takeaways

This study evaluates a specific hip replacement component already in use.
It aims to check long-term performance and safety of the cemented TrendHip® stem.
Participation involves two follow-up appointments after your surgery.
You'll receive standard medical care; no experimental treatments are involved.
Your contribution helps improve understanding for future hip replacement patients.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. You also must have had, or be about to have, a hip replacement operation where the cemented TrendHip® stem was used, following your doctor's usual recommendations.

It's important that you are happy to take part in the study. If you're not comfortable with it, you won't be included.

You won't be able to join if your doctors believe you have a health condition that means you might not live for a long time. Also, if you know you won't be able to come to the follow-up appointments, then you wouldn't be suitable for this study.

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?
Are you having, or have you had, a hip replacement using the 'cemented TrendHip®' part?
Are you happy and willing to take part in the study?
Are you able to attend two follow-up appointments after your surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be given any new medication or different treatments. You'll receive the standard hip replacement surgery with the cemented TrendHip® stem, just as your doctor would normally recommend.

The main part of your participation involves attending two follow-up appointments. These appointments will happen after your hip replacement surgery. During these visits, doctors will check how your new hip is doing and ask about your health and any pain you might be experiencing. The total duration of your participation will depend on when these two follow-up checks are scheduled, but it mostly involves just those two extra visits.

Potential risks and benefits

Taking part in this study generally carries very low additional risks, as you would be receiving the standard hip replacement procedure that your doctor has already recommended. There are no experimental treatments involved. Potential benefits include helping doctors and manufacturers understand how well the cemented TrendHip® stem works in real-world patients, which can improve care for future patients. You might also feel a sense of contribution to medical knowledge. Remember, you have the right to withdraw from the study at any time without it affecting your medical care.

Locations (4)

St. Franziskus-Hospital
Verified postcode
Ahlen, Germany
St. Vincenz Hospital Brakel
Verified postcode
Brakel, Germany
St. Marien-Hospital
Verified postcode
Mülheim, Germany
radprax Krankenhaus Plettenberg GmbH
Verified postcode
Plettenberg, Germany

Common questions

What specifically is being studied?

This study is looking at how well a specific hip replacement part, called the cemented TrendHip® stem, performs and if it's safe for patients.

Do I need to do anything different for my surgery?

No, you would receive the same hip replacement surgery and care as patients not in the study.

Are there any extra tests I'll need?

You'll have two follow-up appointments after your surgery where doctors will check on your new hip and your health.

Who is paying for this study?

This is a 'Post Market Clinical Follow-Up' study, usually supported by the company that makes the hip replacement part.

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.