RecruitingOBSERVATIONAL

Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty

This study is checking a new digital tool called Pheno4U for people having total knee replacement surgery. This tool collects important information about how a patient is doing after their operation. It records details like how much the knee can bend and move, and also gathers answers to health questionnaires. The main goal is to understand important factors about the patient and their knee implant to help doctors choose the best treatments for each person. The information is collected during regular check-ups, and patients will also use a special sensor and app to track their knee movement.

At a glance

Status

Recruiting

Sponsor

Aesculap AG

Enrolment target

600

Start

28 Sep 2022

Estimated completion

01 Mar 2028

Degenerative Osteoarthritis Rheumatoid Arthritis Posttraumatic Arthropathy Chronic Instability of Knee Stiffness of Knee Deformity Knee

What is this study about?

Imagine you're having an operation to replace your knee. This study is testing a new digital system called Pheno4U. Think of it as a smart way to gather information about your new knee and your recovery after surgery. Doctors want to understand what makes a knee replacement most successful for different people. By collecting detailed information, they hope to make future treatments even better and more personal for each patient.

This system will be used during your regular visits to the clinic, just as your doctor would normally check on you. The information gathered might include details about your health and how your specific knee implant is working. The aim is to spot important patterns and risk factors that could affect how well your knee heals and functions.

Your involvement would help doctors learn more about total knee replacement and how to improve care. It's about using modern tools to understand real-world results and make sure future patients get the best possible outcome for their new knee.

Key takeaways

It's about gathering information to improve future knee replacement care.
You'll use a sensor and app to track your knee movement.
Your medical treatment will be exactly the same as standard care.
The study helps doctors understand factors for successful recovery.
It involves regular data collection during your usual check-ups.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) who is having a full knee replacement operation using a specific type of knee implant from a company called B. Braun. You also need to be happy to sign a consent form, which means you understand what the study involves and agree to take part.

It's important that you are willing and able to use a special sensor called "BPMpathway" and an app called "4Patient". These tools help to measure how well your knee is moving and to collect other health information.

You wouldn't be able to join if you are under 18, if you're pregnant, or if you decide you don't want to continue with the follow-up checks. Also, if a different brand of knee implant is used during your surgery, you wouldn't be able to stay in this particular 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 a total knee replacement with a B. Braun implant?
Are you happy to sign a consent form?
Are you willing and able to use a special sensor and app on a smartphone?
Are you willing to participate in follow-up checks?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't be given any new or different treatments; the medical care you receive will be what your doctor would normally provide after a knee replacement. The main part of your involvement will be allowing your medical information to be collected. This data, which is gathered during your regular check-ups, will be put into the Pheno4U data platform.

You will also be asked to fill out questionnaires about your health as part of your routine follow-up. Additionally, you'll use a special sensor called "BPMpathway" and a related app on a smart device. This sensor helps measure how much your knee can bend and move. It can also be used for exercises before and after your operation. The total length of your participation would depend on your recovery and the regular follow-up schedule for your knee replacement.

Potential risks and benefits

Taking part in this study means your health information will help doctors learn more about knee replacement surgery, potentially improving care for others in the future. You won't receive different treatment than usual, nor will there be any direct medical benefits for you from participating. There are minimal risks as the study only involves collecting data from your routine care and using an app/sensor that you can also use for exercises. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (4)

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

Vincentius Krankenhaus
Verified postcode
Konstanz, Germany· Recruiting
Universitätsklinikum Carl Gustav Carus
Verified postcode
Dresden, Germany· Not yet recruiting
Waldkliniken Eisenberg
Verified postcode
Eisenberg, Germany· Recruiting
Nottingham University Hospital NHS Trust
Verified postcode
Nottingham, United Kingdom· Not yet recruiting

Common questions

What is Pheno4U?

Pheno4U is a digital platform, like a secure online system, used to collect and organise health information from patients after knee replacement surgery.

Will I get different treatment if I join?

No, you will receive the exact same medical care and treatment that your doctor would normally provide for your knee replacement.

What is the 'BPMpathway' sensor?

It's a small device you wear or use that measures how well your knee moves and bends. It can also guide you through exercises.

Who can see my information?

Your medical information will be collected securely and used for research purposes by the study team. Your personal details will be kept private.

How long does the study last for me?

Your participation will match the usual follow-up time for your total knee replacement surgery. There isn't a separate, fixed study duration.

How to find out more

Stefan Maenz

studies@aesculap.de +49746195 Official trial record

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