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Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1
Sponsor: Aesculap AG
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.
Official title: Prospective, Single-arm, Multicenter Study to Evaluate the Performance of Navigated Total Knee Arthroplasty Using the OrthoPilot and the Software pheno4u TKA Level 1
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2025-10-07
Completion Date
2028-06
Last Updated
2025-11-17
Healthy Volunteers
No
Interventions
Navigated Total Knee Arthroplasty
The OrthoPilot® Software Pheno4u TKA Level 1 is an application software for computer aided navigation of surgical instruments and serves (in combination with compatible hardware and compatible navigated instruments) as an optional aid for the surgeon during the preparation of the implant site for a compatible knee endoprosthesis.
Locations (4)
Šumperk Hospital Inc.
Šumperk, Czechia
Klinikum Konstanz GmbH
Konstanz, Baden-Wurttemberg, Germany
Park-Klinik Weißensee
Berlin, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Germany