Evaluating a data platform for patients undergoing knee replacement surgery
Official title: Prospective, Multinational Pilot Study for Evaluation of the PHENO4U Data Platform in Total Knee Arthroplasty Patients
Run by Aesculap AG · NCT05302934 · Data updated 2026-11-12
This study is testing a new data platform to see how it can help patients who are getting knee replacement surgery by tracking their recovery and improving their care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 4 sites (Konstanz, Baden-Wurttemberg and 3 other locations) |
| Status | Recruiting |
| Started | September 28, 2022 |
| Main results expected | June 2027 |
| Study ends | March 2028 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT05302934 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients aged 18 and older who are scheduled for total knee arthroplasty with a B. Braun knee implant and are willing to participate in follow-up assessments.
✕Probably not a fit
Patients under 18, those unwilling to participate in follow-up, pregnant individuals, or those receiving implants from manufacturers other than B. Braun will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the Pheno4U data platform in patients receiving Total Knee Arthroplasty (TKA) with Aesculap implants. It will collect and analyze patient and implant data to identify critical risk factors and optimize patient-centered therapies. Participants will complete health questionnaires and use a sensor and application to measure their range of motion and assist with pre- and postoperative training. The study is designed to enhance understanding of outcomes in knee replacement surgeries.
Why it matters
Potential benefit: If successful, this study could lead to improved patient outcomes and tailored therapies for individuals undergoing knee replacement surgery.
How similar studies have gone: Other studies utilizing data platforms for orthopedic outcomes have shown promise, suggesting that this approach may yield valuable insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Vincentius Krankenhaus
Konstanz, Baden-Wurttemberg, Germany Recruiting -
Waldkliniken Eisenberg
Eisenberg, Thuringia, Germany Recruiting -
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, Germany Not yet recruiting -
Nottingham University Hospital NHS Trust
Nottingham, United Kingdom Not yet recruiting
Study contacts
- Principal investigator: Jörg Lützner, Prof. Dr. — Universitätsklinikum Carl Gustav Carus
- Study coordinator: Stefan Maenz
- Email: studies@aesculap.de
- Phone: +49746195
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.