Trials / Recruiting
RecruitingNCT05302934
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Prospective, Multinational Pilot Study for Evaluation of the PHENO4U Data Platform in Total Knee Arthroplasty Patients
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (estimated)
- Sponsor
- Aesculap AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 .
Conditions
- Degenerative Osteoarthritis
- Rheumatoid Arthritis
- Posttraumatic Arthropathy
- Chronic Instability of Knee
- Stiffness of Knee
- Deformity Knee
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-09-28
- Primary completion
- 2027-06-01
- Completion
- 2028-03-01
- First posted
- 2022-03-31
- Last updated
- 2026-02-27
Locations
4 sites across 2 countries: Germany, United Kingdom
Source: ClinicalTrials.gov record NCT05302934. Inclusion in this directory is not an endorsement.