Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
NCT ID: NCT05302934
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2022-09-28
2028-03-31
Brief Summary
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Detailed Description
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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 .
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pheno4U
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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Aesculap AG
INDUSTRY
Responsible Party
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Principal Investigators
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Jörg Lützner, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Carl Gustav Carus
Locations
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Vincentius Krankenhaus
Konstanz, Baden-Wurttemberg, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, Germany
Waldkliniken Eisenberg
Eisenberg, Thuringia, Germany
Nottingham University Hospital NHS Trust
Nottingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AAG-O-H-2113
Identifier Type: -
Identifier Source: org_study_id
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