Clinical Trial

Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1

Study acronym: TKA4U
Recruiting
View on ClinicalTrials.gov →
Summary
The purpose of this PMCF study is to demonstrate the accuracy of navigation using the new pheno4uTKA Level 1 software for OrthoPilot Elite® and to evaluate its safety and performance. Patient-related outcome measures (PROM) will be acquired to investigate functional outcome and patient satisfaction.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-04-25; most recent amendment 2025-11-14.
Status change: Not Yet Recruiting → Recruiting 2025-11-14
Trial Details
NCT Number NCT06955481
Lead Sponsor Aesculap AG
Collaborators: Raylytic GmbH
Conditions Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee, Posttraumatic Arthropathy
Enrollment 120 participants
Start Date 2025-10-07
Primary Completion 2027-07 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2025-11-17