Clinical trial NCT05302934: Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Official title: Prospective, Multinational Pilot Study for Evaluation of the PHENO4U Data Platform in Total Knee Arthroplasty Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Degenerative Osteoarthritis
Rheumatoid Arthritis
Posttraumatic Arthropathy
Chronic Instability of Knee
Stiffness of Knee
Deformity Knee
Keywords: bi-condylar knee replacement
severe knee joint conditions
patient reported outcome
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited consecutively. No selection besides the inclusion and exclusion criteria will take place. Four different TKA implant systems can be used within the study: Columbus, E.motion, Enduro and VEGA according to the instructions for use.

Brief summary: 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 .

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.

Primary outcomes:
measure: Identification of any unknown risks or side effects in Total Knee Arthroplasty by using sensors and patient apps
timeFrame: up to 12 months postoperatively
Secondary outcomes:
measure: Change of Knee Injury and Osteoarthritis Outcome score
timeFrame: 2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery
measure: Change of Hospital for Special Surgery (HSS) Knee Surgery Expectations Survey
timeFrame: 2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery
measure: Change of Pain
timeFrame: 2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery
measure: Patient satisfaction
timeFrame: approximately 9 months after surgery
measure: Net Promoter Score
timeFrame: approximately 12 months after surgery
measure: Change of Depression, Anxiety and Stress Scale - 21 Items
timeFrame: 1 week prior to surgery and 2 weeks postoperatively
measure: Development of Active Range of Motion
timeFrame: up to 3 months after surgery
Other outcomes:
measure: Cumulative Radiological Evaluation
timeFrame: for each x-ray taken in clinical routine up to last follow-up approximately 12 months postoperatively
measure: Cumulative Rate of (Serious) Adverse Events
timeFrame: up to last follow-up approximately 12 months postoperatively
Locations:
city: Konstanz
country: Germany
facility: Vincentius Krankenhaus
state: Baden-Württemberg
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
state: Sachsen
city: Eisenberg
country: Germany
facility: Waldkliniken Eisenberg
state: Thüringen
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital NHS Trust
Study officials:
affiliation: Universitätsklinikum Carl Gustav Carus
name: Jörg Lützner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: