Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting · NCT05302934 · Observational (researchers observe without assigning treatment) · Lead sponsor: Aesculap AG
View the official record on ClinicalTrials.gov →Interventions studied
Pheno4U
What this trial is about
Prospective, multinational pilot study for evaluation of the Pheno4U data platform in Total Knee Arthroplasty (TKA) patients
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
8 locations listed.
- Nottingham University Hospital NHS Trust - Nottingham, United Kingdom
- Nottingham University Hospital NHS Trust - Nottingham, United Kingdom
- Vincentius Krankenhaus - Konstanz, Baden-Wurttemberg, Germany
- Vincentius Krankenhaus - Konstanz, Baden-Wurttemberg, Germany
- Universitätsklinikum Carl Gustav Carus - Dresden, Saxony, Germany
- Universitätsklinikum Carl Gustav Carus - Dresden, Saxony, Germany
- Waldkliniken Eisenberg - Eisenberg, Thuringia, Germany
- Waldkliniken Eisenberg - Eisenberg, Thuringia, Germany