Prospective, Single-arm, Multicenter Study to Evaluate the Performance of Navigated Total Knee Arthroplasty Using the OrthoPilot and the Software pheno4u TKA Level 1
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Indication for a TKA with the OrthoPilot® Navigation System with a Aesculap total knee endo-prosthesis
• Written signed informed consent of patient
• Willingness and mental ability to participate at the long-term follow-up examinations
Locations
Other Locations
Germany
Park-Klinik Weißensee
RECRUITING
Berlin
Universitätsklinikum Carl Gustav Carus
NOT_YET_RECRUITING
Dresden
Klinikum Konstanz GmbH
NOT_YET_RECRUITING
Konstanz
Contact Information
Primary
Heike Oberascher
studies@aesculap.de
+49 7461 95
Backup
Stefan Maenz, Dr.
studies@aesculap.de
+49 7461 95
Time Frame
Start Date: 2025-10-07
Estimated Completion Date: 2028-06
Participants
Target number of participants: 120
Treatments
pheno4u TKA Level 1
Navigation of TKA (Total Knee Arthroplasty) using the new pheno4uTKA Level 1 software for OrthoPilot Elite®.
Related Therapeutic Areas
Sponsors
Leads: Aesculap AG
Collaborators: Raylytic GmbH