Status:
RECRUITING
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Lead Sponsor:
Aesculap AG
Conditions:
Degenerative Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
Prospective, multinational pilot study for evaluation of the Pheno4U data platform in Total Knee Arthroplasty (TKA) patients
Detailed Description
The study will collect data for each patient receiving an Aesculap Total Knee Arthroplasty (TKA) implant. The data set will be analyzed for critical risk factors among implant and patient data in orde...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05302934
Start Date
September 28 2022
End Date
March 1 2028
Last Update
November 17 2025
Active Locations (4)
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1
Vincentius Krankenhaus
Konstanz, Baden-Wurttemberg, Germany, 78464
2
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, Germany, 01307
3
Waldkliniken Eisenberg
Eisenberg, Thuringia, Germany, 07607
4
Nottingham University Hospital NHS Trust
Nottingham, United Kingdom, NG7 2UH