Evaluating a data platform for patients undergoing knee replacement surgery
Prospective, Multinational Pilot Study for Evaluation of the PHENO4U Data Platform in Total Knee Arthroplasty Patients
Aesculap AG · NCT05302934
This study is testing a new data platform to see how it can help patients who are getting knee replacement surgery by tracking their recovery and improving their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aesculap AG (industry) |
| Locations | 4 sites (Konstanz, Baden-Wurttemberg and 3 other locations) |
| Trial ID | NCT05302934 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the Pheno4U data platform in patients receiving Total Knee Arthroplasty (TKA) with Aesculap implants. It will collect and analyze patient and implant data to identify critical risk factors and optimize patient-centered therapies. Participants will complete health questionnaires and use a sensor and application to measure their range of motion and assist with pre- and postoperative training. The study is designed to enhance understanding of outcomes in knee replacement surgeries.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 and older who are scheduled for total knee arthroplasty with a B. Braun knee implant and are willing to participate in follow-up assessments.
Not a fit: Patients under 18, those unwilling to participate in follow-up, pregnant individuals, or those receiving implants from manufacturers other than B. Braun will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient outcomes and tailored therapies for individuals undergoing knee replacement surgery.
How similar studies have performed: Other studies utilizing data platforms for orthopedic outcomes have shown promise, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Konstanz, Baden-Wurttemberg and 3 other locations
- Vincentius Krankenhaus — Konstanz, Baden-Wurttemberg, Germany (RECRUITING)
- Universitätsklinikum Carl Gustav Carus — Dresden, Saxony, Germany (NOT_YET_RECRUITING)
- Waldkliniken Eisenberg — Eisenberg, Thuringia, Germany (RECRUITING)
- Nottingham University Hospital NHS Trust — Nottingham, United Kingdom (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Jörg Lützner, Prof. Dr. — Universitätsklinikum Carl Gustav Carus
- Study coordinator: Stefan Maenz
- Email: studies@aesculap.de
- Phone: +49746195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Degenerative Osteoarthritis, Rheumatoid Arthritis, Posttraumatic Arthropathy, Chronic Instability of Knee, Stiffness of Knee, Deformity Knee, bi-condylar knee replacement, severe knee joint conditions