NCT06955481

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

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
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee
• Joint Diseases
• Rheumatoid Arthritis of Knee
• Posttraumatic Arthropathy

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2025-10-07
• Primary completion: 2027-07-01
• Completion: 2028-06-01
• First posted: 2025-05-02
• Last updated: 2025-11-17

Locations

4 sites across 2 countries: Czechia, Germany