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Clinical Trials in the UK / NCT05302934
Recruiting Observational

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

NCT05302934 · tracked via the Priya Life Science UK tracker
Sponsor
Aesculap AG
Phase
Observational
Started
2022-09-28
Last updated
2026-02-27

Condition(s) studied

Degenerative OsteoarthritisRheumatoid ArthritisPosttraumatic ArthropathyChronic Instability of KneeStiffness of KneeDeformity Knee

Investigational drug(s) / intervention(s)

Pheno4U

Pheno4U: 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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Identification of any unknown risks or side effects in Total Knee Arthroplasty by using sensors and patient apps — up to 12 months postoperatively
    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

Trial sites (4)

FacilityCityRegionStatus
Vincentius Krankenhaus Konstanz Baden-Wurttemberg Recruiting
Universitätsklinikum Carl Gustav Carus Dresden Saxony Not Yet Recruiting
Waldkliniken Eisenberg Eisenberg Thuringia Recruiting
Nottingham University Hospital NHS Trust Nottingham United Kingdom Not Yet Recruiting

More Aesculap AG trials in the UK

Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants Recruiting

Other trials for the same condition

Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis Active, not recruiting
A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR) Active, not recruiting
Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System Active, not recruiting
A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate Active, not recruiting
Safety of Splenic Stimulation for RA Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05302934 on ClinicalTrials.gov ↗ ← All trials in the UK