Overview
Prospective, multinational pilot study for evaluation of the Pheno4U data platform in Total Knee Arthroplasty (TKA) patients
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 order to optimize patient-centered therapies.
The products under investigation will be used in routine clinical practice and according to the Instructions for Use (IFU). Data obtained in routine clinical use will be collected in the Pheno4U data platform. In addition, patients are expected to answer questionnaires about their health status. Furthermore, patients are asked to use the so called "BPMpathway" sensor and application in order to measure the active Range of Motion (ROM). The sensor can also be used for pre- and postoperative training .
Eligibility
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.