Active not recruitingOBSERVATIONAL

Longterm-Evaluation of Vitelene® Against Standard

This research is a long-term study comparing two different types of hip replacement parts used for people with hip arthritis. Both parts are made from a special plastic, but one has Vitamin E added to it. The main aim is to see which type of hip replacement lasts longer and performs better over time. Researchers will be checking for things like how well the implant stays in place, how much the plastic wears down, and if any bone around the implant starts to thin. This study is taking place in several hospitals and will involve people aged between 18 and 75 having a total hip replacement.

At a glance

Status

Active not recruiting

Sponsor

Aesculap AG

Enrolment target

400

Start

01 Jan 2012

Estimated completion

01 Jun 2030

Osteoarthritis, Hip Arthritis

What is this study about?

This study is looking into hip replacements for people who have hip arthritis. When you have a total hip replacement, the damaged part of your hip joint is replaced with artificial parts. One of these parts is a special plastic material which helps the joint move smoothly.

In this study, doctors want to compare two slightly different versions of this plastic part. One version has Vitamin E added to it, and the other doesn't. Researchers believe that adding Vitamin E might help the plastic last even longer and cause fewer issues like wear and tear or thinning of the bone around the new joint. They want to see which one works best in the long run.

By carefully watching people who receive these different hip replacement parts over many years, the study hopes to find out if adding Vitamin E makes a real difference. The goal is to improve hip replacement surgery so that people can have good results and pain relief for as long as possible.

Key takeaways

Compares two types of hip replacement plastic, one with Vitamin E.
Aims to find out which hip replacement lasts longer and works best.
For adults aged 18-75 having a specific type of hip replacement.
Involves regular check-ups and X-rays after surgery.
Participation is voluntary and you can leave at any time.

Who may be eligible?

To be considered for this study, you would generally need to be an adult between 18 and 75 years old. You should be planning to have a 'cementless' total hip replacement for your arthritis. You also need to be willing and able to come to all your follow-up appointments and scans as part of the study.

There are several reasons why someone might not be able to join. For example, if you have a serious illness like cancer, advanced heart or lung problems, or if you're pregnant. If you've had previous surgery on the same hip, a recent broken bone in that hip, or issues with bone quality, you might not be suitable. Also, certain factors about the size or shape of your hip, or specific parts needed for your surgery, could mean you can't take part.

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?
Are you having a cementless total hip replacement for arthritis?
Are you willing and able to attend all follow-up appointments?
Do you have good overall health and no serious unmanaged conditions?
Have you not had previous surgery or injury to the same hip joint recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either a standard hip replacement part or one with added Vitamin E, chosen at random. This means neither you nor your doctor can choose which type you receive. After your surgery, you would need to attend regular follow-up appointments at the hospital. These appointments will involve check-ups and X-rays to see how your new hip is doing and to check for any wear or bone changes. The study aims to follow you for a long time to see the long-term results of your hip replacement.

Potential risks and benefits

Taking part in a study like this could mean you receive a hip replacement part that lasts longer or causes fewer problems in the future, potentially improving your quality of life. However, as with any surgery, there are always risks, including those related to the operation itself, anaesthesia, and potential complications with the implant. It's important to remember that you are free to leave the study at any time, for any reason, without affecting your standard medical care.

Locations (6)

Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef
Verified postcode
Bendorf, Germany
Klinik für Orthopädie und Unfallchirurgie
Verified postcode
Bochum, Germany
Klinik und Poliklinik für Orthopädie
Verified postcode
Halle, Germany
Orthopädische Klinik der MHH im Annastift
Verified postcode
Hanover, Germany
St. Marien Hospital
Verified postcode
Mülheim, Germany
Elisabeth Klinikum Olsberg
Verified postcode
Olsberg, Germany

Common questions

What is 'Osteoarthritis of the Hip'?

Osteoarthritis is a common type of arthritis where the smooth cartilage covering the ends of bones in your hip joint wears away over time, causing pain and stiffness.

What is a 'cementless total hip replacement'?

A cementless hip replacement uses specially designed parts that grow into your own bone, rather than being fixed with bone cement.

What does 'Vitelene' or 'Highly Cross-linked Polyethylene (UHMWPE-XE)' mean?

These are names for the special plastic material used in hip replacements. Some versions have Vitamin E added to make them potentially more durable.

Will I know which type of hip replacement I get?

No, in this study, the type of hip replacement you receive (with or without Vitamin E) is chosen randomly, so neither you nor your doctor will decide.

How long will I be followed in this study?

This is a 'long-term' study, meaning doctors will monitor your hip replacement and recovery over many years to see how the different parts perform over time.