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Actively Recruiting

Age: 18Years +
All Genders
ID05302934

Multinational Pilot Study Evaluating the PHENO4U Data Platform in Patients Receiving Total Knee Arthroplasty with Aesculap Implants

Led by Aesculap AG · Updated on 2026-02-27

600

Participants Needed

4

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the Pheno4U data platform in patients undergoing Total Knee Arthroplasty TKA to collect and analyze implant and patient data. This prospective, multinational pilot study includes adult patients receiving an Aesculap TKA implant, aiming to identify critical risk factors and optimize patient-centered therapies for conditions such as degenerative osteoarthritis and rheumatoid arthritis. Each patient will receive an Aesculap TKA implant as part of their routine clinical care. Data will be gathered through the Pheno4U platform, including patient responses to health questionnaires and measurements of active Range of Motion ROM using the BPMpathway sensor and application. This sensor can also support patients with pre- and postoperative training. Participants will be monitored up to 12 months post-surgery with various assessments, including changes in knee injury and osteoarthritis scores, pain levels, patient satisfaction, and psychological status. The study will track the development of active ROM for up to three months and identify any unknown risks or side effects related to the knee arthroplasty using sensor and app data. The study duration and follow-up are designed to gather comprehensive patient outcome information.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient undergoing a total knee arthroplasty with a B. Braun knee implant system
  • Signed written informed consent
  • Patient's willingness and ability to use the "BPMpathway" sensor
  • Patient's willingness and ability to use the "4Patient" application
Not Eligible

You will not qualify if you...

  • Patient age under 18 years
  • Patient not willing to participate at the further follow-up
  • Pregnancy
  • Use of an implant from a different manufacturer during surgery

Research Team

S

Stefan Maenz

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