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Smart knee replacement: data platform aims to cut risks

NCT ID NCT05302934

Knowledge-focused Sponsor: Aesculap AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study will enroll 600 people getting total knee replacements to test a data platform called Pheno4U. Participants will use a sensor and a smartphone app to track their recovery. The goal is to identify unknown risks or side effects and improve personalized care. The study does not test a new drug or implant, but rather a way to collect and analyze patient data.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pheno4U data platform (device and app-based monitoring)
What this could lead to
If successful, this could help doctors personalize knee replacement care and reduce complications by spotting risks early.
What could go wrong
This is an early pilot study focused on data collection, not a treatment test. It may not lead to direct patient benefits or change standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients will be recruited consecutively. No selection besides the inclusion and exclusion criteria will take place. Four different TKA implant systems can be used within the study: Columbus, E.motion, Enduro and VEGA according to the instructions for use.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient undergoing a total knee arthroplasty with a B. Braun knee implant system * Signed written informed consent * Patient's willingness \& ability to use the "BPMpathway"sensor * Patient's willingness \& ability to use the "4Patient" application Exclusion Criteria: * Patient age \< 18 years * Patient not willing to participate at the further follow-up * Pregnancy * If intraoperatively an implant from a different manufacturer is used, the study patient has to be excluded from the study.

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Conditions

The condition(s) this trial relates to.

arthropathy osteoarthritis rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic instability of knee Deformity knee Degenerative osteoarthritis Posttraumatic arthropathy Rheumatoid arthritis Stiffness of knee

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Nottingham University Hospital NHS Trust

    NOT_YET_RECRUITING

    Nottingham, NG7 2UH, United Kingdom

  • Universitätsklinikum Carl Gustav Carus

    NOT_YET_RECRUITING

    Dresden, Saxony, 01307, Germany

  • Vincentius Krankenhaus

    RECRUITING

    Konstanz, Baden-Wurttemberg, 78464, Germany

  • Waldkliniken Eisenberg

    RECRUITING

    Eisenberg, Thuringia, 07607, Germany

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