RecruitingOBSERVATIONAL

Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up

This study is investigating a particular type of artificial hip joint called MobileLink, which is used for hip replacements, often due to conditions like osteoarthritis. Hip replacement surgery is very common, and most patients are happy with the results. The MobileLink system is certified for safety and performance in Europe. This study aims to gather real-world information on how well the MobileLink hip joint performs over time, looking at both its clinical success and how satisfied patients are. Researchers will collect data from people who have already received this specific hip replacement as part of their routine care. It's about understanding the long-term effectiveness and patient experience with this widely used medical device.

At a glance

Status

Recruiting

Sponsor

Waldemar Link GmbH & Co. KG

Enrolment target

520

Start

04 May 2021

Estimated completion

01 Jan 2036

Osteoarthritis, Hip Hip Osteoarthritis Prosthesis Survival Prosthesis Failure

What is this study about?

This study focuses on a type of artificial hip joint called MobileLink, which is used in hip replacement surgery. Hip replacement is a very common operation, especially for people suffering from osteoarthritis, a condition that causes wear and tear in the joints. Most people who have a hip replacement find that it significantly improves their quality of life.

The MobileLink system has met European safety and performance standards, meaning it's approved for use. The main goal of this study is to see how this particular hip replacement performs in real-life situations. Researchers want to understand its long-term success, how well it functions, and importantly, how happy patients are with their new hip in the years after surgery.

By collecting information from people who have already received a MobileLink hip, the study hopes to provide valuable insights into its effectiveness and durability. This helps doctors and manufacturers ensure that future patients continue to receive the best possible care and that these artificial joints meet their needs over many years.

Key takeaways

The study looks at an artificial hip called MobileLink.
It aims to see how well the hip works and how happy patients are over time.
Information is collected from existing medical records from routine care.
Participation involves no new procedures or medicines.
The findings will help improve future hip replacement care.

Who may be eligible?

To be included in this study, you would already need to have had a specific artificial hip joint called the MobileLink acetabular cup and a matching thigh bone component, both made by Waldemar Link, implanted during your hip replacement surgery. You must also be at least 18 years old when you had the surgery and have given your written consent to participate.

However, some people would not be included. If you've had a previous hip replacement surgery that needed to be redone or revised, you wouldn't qualify. Similarly, if your body mass index (BMI) is 40 or higher, you wouldn't be eligible. The study also needs participants who can understand what's involved and are likely to follow up regularly; if this isn't possible, you wouldn't be included.

Additionally, pregnant or breastfeeding women, as well as individuals who are currently in prison, would not be able to take part in this study. The aim is to ensure the study population provides clear, reliable information about the MobileLink hip in typical, uncomplicated situations.

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.

I have had a MobileLink hip replacement.
I am 18 years old or older.
My hip replacement was not a 'revision' (a redo of a previous replacement).
I am not pregnant or breastfeeding.
I can understand the study information.

Answer every question to see your result.

What does participation involve?

This study is gathering information from people who have already had the MobileLink hip replacement as part of their usual medical care. This means you wouldn't be asked to undergo any extra procedures or take new medications specifically for the study. Instead, researchers would collect relevant health information about your hip replacement from your existing medical records over time. This includes details about how your hip is functioning and your satisfaction with it during your regular follow-up appointments with your surgeon. The total duration of your participation would depend on how long you've had your hip replacement and how much long-term data is being collected from your routine care.

Potential risks and benefits

As this study primarily involves reviewing existing medical records and routine follow-up information, there are no additional physical risks or procedures for participants. Your privacy will be protected, and your personal data handled confidentially. The potential benefit is that the information gathered will help doctors and manufacturers better understand the long-term performance and patient satisfaction with the MobileLink hip system, which can lead to improved care for future patients. Participants always have the right to withdraw their consent at any time, without affecting their medical care.

Locations (2)

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

Lubinus Stiftung
Verified postcode
Kiel, Germany· Recruiting
NHS FIFE Victoria Hospital
Verified postcode
Kirkcaldy, United Kingdom· Recruiting

Common questions

What is osteoarthritis?

Osteoarthritis is a common condition that causes joints to become painful and stiff. It's often called 'wear and tear' arthritis because it happens when the smooth cushion (cartilage) on the ends of bones wears down over time.

What is a hip prosthesis?

A hip prosthesis is an artificial hip joint. It's used to replace a damaged hip joint, typically during a hip replacement operation, to help relieve pain and improve movement.

What does 'CE marked' mean for a medical device?

A 'CE mark' on a medical device means that it meets European safety, health, and environmental protection requirements. It's a bit like a quality assurance stamp, showing the device is safe and performs as intended.

Will I have to do anything differently if I participate?

No, this study uses information from your existing medical records and routine follow-up appointments. You won't need to do anything extra or have any new treatments or tests for the study.

Could this study change my medical care?

No, participating in this study will not change how your doctors manage your hip replacement or your ongoing medical care. Your treatment decisions remain between you and your healthcare team.

How to find out more

Lisa Skottke, PhD

l.skottke@link-ortho.com +494053995673 Official trial record

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