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

Plain Language Summary

Simplified for easier understanding

This study evaluates PHENO4U, a digital health platform that tracks recovery for people having a total knee replacement (knee joint surgery). Patients use a wearable sensor and a smartphone app to monitor their progress before and after surgery. **You may be eligible if...** - You are 18 or older and scheduled for a total knee replacement using a B. Braun knee implant - You are comfortable using a wearable sensor (BPMpathway) and a smartphone app (4Patient) - You are willing to attend follow-up visits **You may NOT be eligible if...** - You are under 18 years old - You are pregnant - A different brand of knee implant is used during your surgery - You are not willing to participate in follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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