Menu
Recruiting NCT05302934

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

— Observational Degenerative Osteoarthritis Rheumatoid Arthritis Posttraumatic Arthropathy Chronic Instability of Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pheno4U.
Who it may be relevant to
Registry conditions: Degenerative Osteoarthritis, Rheumatoid Arthritis, Posttraumatic Arthropathy, Chronic Instability of Knee. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed 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 .

Interventions

  • Device 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

Primary outcome measures

  • Identification of any unknown risks or side effects in Total Knee Arthroplasty by using sensors and patient apps [Time frame: up to 12 months postoperatively]
Secondary outcome measures (7)
  • Change of Knee Injury and Osteoarthritis Outcome score [Time frame: 2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery]
  • Change of Hospital for Special Surgery (HSS) Knee Surgery Expectations Survey [Time frame: 2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery]
  • Change of Pain [Time frame: 2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery]
  • Patient satisfaction [Time frame: approximately 9 months after surgery]
  • Net Promoter Score [Time frame: approximately 12 months after surgery]
  • Change of Depression, Anxiety and Stress Scale - 21 Items [Time frame: 1 week prior to surgery and 2 weeks postoperatively]
  • Development of Active Range of Motion [Time frame: up to 3 months after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 3 centers
  • Vincentius Krankenhaus — Konstanz
  • Universitätsklinikum Carl Gustav Carus — Dresden
  • Waldkliniken Eisenberg — Eisenberg
United Kingdom · 1 center
  • Nottingham University Hospital NHS Trust — Nottingham

Identifiers

NCT: NCT05302934 · AAG-O-H-2113

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗