RecruitingNCT05302934

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

Prospective, Multinational Pilot Study for Evaluation of the PHENO4U Data Platform in Total Knee Arthroplasty Patients

Sponsor

Aesculap AG

Enrollment

600 participants

Start Date

Sep 28, 2022

Study Type

OBSERVATIONAL

Conditions

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

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria4

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.

Interventions

DEVICEPheno4U

Total Knee Arthroplasty represents a well-established, reliable and successful treatment option for end-stage bicompartmental osteoarthritis or other indications resulting in joint destruction. In general, Implantation of a total knee prosthesis improves the quality of life through pain alleviation, deformity correction, joint stabilization, and/or functional range of motion (ROM) through restoration of normal knee kinematics and functionality