Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty (Pheno4U Pilot)

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

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

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Degenerative Osteoarthritis; Posttraumatic Arthropathy; Chronic Instability of Knee; Stiffness of Knee; Deformity Knee
• Intervention / Treatment: Device: Pheno4U

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 .

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Stefan Maenz; Phone Number: +49746195; Email: studies@aesculap.de

Study Locations

• Germany
  • Baden-Wurttemberg
    • Konstanz, Baden-Wurttemberg, Germany, 78464
      • Recruiting
      • Vincentius Krankenhaus
      • Contact: Gunnar B Ochs, Prof. Dr.; Email: gunnar.ochs@glkn.de
      • Principal Investigator: Gunnar B Ochs, Prof. Dr.
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Not yet recruiting
      • Universitätsklinikum Carl Gustav Carus
      • Contact: Jörg Lützner, Prof. Dr.; Email: joerg.luetzner@uniklinikum-dresden.de
      • Principal Investigator: Jörg Lützner, Prof. Dr.
  • Thuringia
    • Eisenberg, Thuringia, Germany, 07607
      • Recruiting
      • Waldkliniken Eisenberg
      • Contact: Georg Matziolis, Prof. Dr.; Email: G.Matziolis@waldkliniken-eisenberg.de
      • Principal Investigator: Georg Matziolis, Prof. Dr.
• United Kingdom
  • Nottingham, United Kingdom, NG7 2UH
    • Not yet recruiting
    • Nottingham University Hospital NHS Trust
    • Contact: Khosrow Sehat; Email: Khosrow.Sehat@nuh.nhs.uk
    • Principal Investigator: Khosrow Sehat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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; Other Names: Total Knee Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of any unknown risks or side effects in Total Knee Arthroplasty by using sensors and patient apps	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	up to 12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Knee Injury and Osteoarthritis Outcome score	The Patient self-assessed Injury and Knee Osteoarthritis Outcome Scores (KOOS) is a joint-specific instrument: The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.	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	The Hospital for Special Surgery (HSS) Knee Surgery Expectations Survey is a 17 item questionnaire. The survey is comprised of five different categories of expectations: pain, walking, psychological state, essential activities and non-essential activities. The responses range from ''very important'' (score: 1) to ''this does not imply to me'' (score: 5). The total summed raw score ranges from 0 to 76 and the transformed score [ = (raw score/76)×100] ranges from 0 to 100. Higher scores indicate expecting more improvement for more items.	2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery
Change of Pain	Information on pain is collected by the so called "painDETECT" questionnaire, a self-reported screening tool for the identification of neuropathic pain. The questionnaire contains seven weighted sensory descriptors, one item relating to spatial pain characteristics and one item relating to temporal characteristics. A total score ranging from -1 to 38 can be calculated. The total score is divided into three categories (unlikely neuropathic pain (<13), unclear (13-18), likely neuropathic pain (>18)).	2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery
Patient satisfaction	Based on a single question 9 months after surgery patients are asked to grade their level of satisfaction with the methodology and rehabilitation procedure. They can choose between "very dissatisfied", "dissatisfied", "satisfied" or "very satisfied".	approximately 9 months after surgery
Net Promoter Score	The Net Promoter Score (NPS) is an index ranging from -100 to 100 that measures the willingness of patients to recommend the treatment to others. It is used as a proxy for gauging the patient's overall satisfaction with a treatment. Patients are surveyed on one single question. They are asked to rate on an 11-point scale the likelihood of recommending the treatment to a friend or colleague. "On a scale of 0 to 10, how likely are you to recommend the same treatment to a friend or a colleague?" Based on their rating, customers are then classified in 3 categories: detractors, passives and promoters. 'Detractors' gave a score lower or equal to 6. 'Passives' gave a score of 7 or 8. 'Promoters' answered 9 or 10. The NPS is determined by subtracting the percentage of customers who are detractors from the percentage who are promoters.	approximately 12 months after surgery
Change of Depression, Anxiety and Stress Scale - 21 Items	The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items with a four point rating scale (ranging 0 - 3 points) for each item. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. The total score is calculated by summing the scores for the relevant items, the minimum score is 0 points, the maximum score for each section is 21. A lower score represents less depression, anxiety and stress.	1 week prior to surgery and 2 weeks postoperatively
Development of Active Range of Motion	The active Range of Motion (ROM) is measured with the BPMpathway sensor and application 3 times per day for the entire duration of usage of the sensor. In general, the sensor is used for pre- and postoperative training. Patients are expected to use the sensor from pre-op consultation up to 3 month after surgery.	up to 3 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Radiological Evaluation	Imaging will be used to evaluate the implant status as well as device condition and potential presence of device-related Adverse Events including fracture, wear, loosening or radiolucencies.	for each x-ray taken in clinical routine up to last follow-up approximately 12 months postoperatively
Cumulative Rate of (Serious) Adverse Events	During the course of the study any upcoming intra- or postoperative (serious) adverse events directly or possibly related to the products under investigation will be documented in the dedicated electronic case report forms (eCRFs). Recorded complications will be categorized and analyzed in order to assess the safety of the investigational products.	up to last follow-up approximately 12 months postoperatively

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Jörg Lützner, Prof. Dr., Universitätsklinikum Carl Gustav Carus

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: patient reported outcome; bi-condylar knee replacement; severe knee joint conditions
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Arthritis, Rheumatoid; Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation; Arthroplasty, Replacement, Knee
• Other Study ID Numbers: AAG-O-H-2113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No