Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty (Pheno4U Pilot)

Aesculap

Status: Enrolling

Conditions: Chronic Instability of Knee; Degenerative Osteoarthritis; Stiffness of Knee; Deformity Knee; Posttraumatic Arthropathy; Rheumatoid Arthritis

Treatments: Device: Pheno4U

Study type: Observational

Funder types: Industry

Identifiers

NCT05302934

AAG-O-H-2113

Details and patient eligibility

About

Prospective, multinational pilot study for evaluation of the Pheno4U data platform in Total Knee Arthroplasty (TKA) patients

Full 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 .

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 1 patient group

Pheno4U

Description:

The study will collect data for each patient receiving an Aesculap TKA implant. The data set will be analyzed for critical risk factors among implant and patient data in order to optimize patient-centered therapies.

Treatment:

Device: Pheno4U