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Search / Trial NCT05302934

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

Launched by AESCULAP AG · Mar 22, 2022

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Bi Condylar Knee Replacement Severe Knee Joint Conditions Patient Reported Outcome

ClinConnect Summary

This clinical trial, called the PHENO4U study, is looking at a new data platform designed to help patients who are having total knee replacement surgery, also known as total knee arthroplasty. The study aims to understand how this platform can assist in monitoring and improving patient care during the recovery process for those suffering from knee problems like arthritis or knee stiffness. Currently, the trial is recruiting participants aged 65 and older who will receive a specific knee implant and are willing to use some special tools, like a sensor and a mobile app.

If you or a loved one is considering joining this study, you would need to be at least 65 years old and plan to have the B. Braun knee implant. Participants will be asked to provide consent and agree to follow up after their surgery. It’s important to note that individuals under 18, those who are pregnant, or those who may have a different implant used during surgery cannot participate. Joining this study could provide valuable insights into how technology can improve knee surgery recovery, and it offers a chance to be part of a new approach to patient care.

Gender

ALL

Eligibility 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.

About Aesculap Ag

Aesculap AG is a prominent global medical device manufacturer specializing in surgical instruments, implants, and innovative healthcare solutions. With a rich history rooted in excellence and innovation, Aesculap AG is dedicated to advancing surgical practices through cutting-edge technology and a commitment to improving patient outcomes. The company collaborates with healthcare professionals and institutions to conduct clinical trials that evaluate the safety and efficacy of its products, ensuring that they meet the highest standards of quality and performance. Through its rigorous research and development initiatives, Aesculap AG aims to contribute significantly to the field of medicine and enhance the standards of surgical care worldwide.

Locations

Dresden, Sachsen, Germany

Nottingham, , United Kingdom

Eisenberg, , Germany

Konstanz, Baden Württemberg, Germany

Eisenberg, Thüringen, Germany

Konstanz, , Germany

Patients applied

0 patients applied

Trial Officials

Jörg Lützner, Prof. Dr.

Principal Investigator

Universitätsklinikum Carl Gustav Carus

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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