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

NCT05302934 | Recruiting

• 1 other identifier: AAG-O-H-2113
• Study Type: observational
• Target: 600
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Deformity Knee; Degenerative Osteoarthritis; Rheumatoid Arthritis; Posttraumatic Arthropathy; Chronic Instability of Knee; Stiffness of Knee

Keywords

bi-condylar knee replacement; severe knee joint conditions; patient reported outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change of Knee Injury and Osteoarthritis Outcome score

  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

  2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery

• Change of Pain

  2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery

• Patient satisfaction

  approximately 9 months after surgery

• Net Promoter Score

  approximately 12 months after surgery

Other Outcomes (2)

• Cumulative Radiological Evaluation

  for each x-ray taken in clinical routine up to last follow-up approximately 12 months postoperatively

• Cumulative Rate of (Serious) Adverse Events

  up to last follow-up approximately 12 months postoperatively

Study Arms (1)

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

Interventions

Pheno4U DEVICE

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

Also known as: Total Knee Arthroplasty

Pheno4U

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (4)

Vincentius Krankenhaus

Konstanz, Baden-Wurttemberg, 78464, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, 01307, Germany

NOT YET RECRUITING

Waldkliniken Eisenberg

Eisenberg, Thuringia, 07607, Germany

RECRUITING

Nottingham University Hospital NHS Trust

Nottingham, NG7 2UH, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Joint Diseases; Arthritis, Rheumatoid

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Jörg Lützner, Prof. Dr.

  Universitätsklinikum Carl Gustav Carus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Maenz

CONTACT

+49746195; studies@aesculap.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: September 28, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); GB (1)